Datascope Corporation Recalls
Showing 1-16 of 16 recalls
Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories is a device that includes a catheter, an insertion kit and two STATLOCK IAB stabilization devices. It is a cardiac assist device intended to provide counterpulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle a
The device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. This showed the product as expired before it was manufactured.
An Urgent Medical Device Recall notification letters dated 5/28/19 was sent to the customer. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached URGENT MEDICAL DEVICE RECALL CUSTOMER RESPONSE FORM on page 3, to acknowledge that you have received the Sensation Plus 7.5 Fr. 40cc Intra-Aortic Balloon Catheter with Accessories URGENT MEDICAL DEVICE RECALL. Please fax or email the completed Customer Response Form to 1-585-486-5605.
Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an accessory to be used for percutaneous insertion of MAQUET Intra Aortic Balloon Catheters.
Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
On December 11, 2019 the firm distributed Urgent Medical Device Recall Communication letters by FedEx 2 day delivery with signature proof of delivery stating: URGENT MEDICAL DEVICE RECALL REMOVAL MAQUET 7Fr., 7.5Fr. and 8Fr. REINFORCED INTRODUCER SETS PLEASE FORWARD THIS INFORMATION TO ALL CURRENT AND POTENTIAL USERS OF REINFORCED INTRODUCER SETS FOR MAQUET 7 Fr., 7.5 Fr. AND 8 Fr. INTRA-AORTIC BALLOON (IAB) WITHIN YOUR HOSPITAL OR FACILITY. IF YOU HAVE FURTHER DISTRIBUTED ANY OF THE AFFECTED PRODUCTS, FORWARD THIS INFORMATION TO THE RECIPIENT. Dear Risk Manager, Datascope / Maquet Getinge is initiating a voluntary Medical Device Recall Removal of the Reinforced Introducer Sets for Maquet 7 Fr., 7.5 Fr.and 8 Fr. IAB (Intra Aortic Balloon) due to a potential breach in the Mylar side (clear plastic) of the pouch, which could compromise device sterility. Identification of the issue: During the execution of a remediation protocol for re-verification of packaging, Datascope / Maquet Getinge found a small slit on the Mylar side (clear plastic) of the pouch of one device. Imprints of the sharp corners of the polystyrene strip used in packaging were observed around the slit, which likely caused the breach in the pouch compromising the sterility of the device. Risk to Health Adequate packaging and packaging materials are essential to help preserve the sterility of medical devices. Improperly sterilized medical devices may pose a serious risk of patient infection, including pyrogenic reaction, inflammatory response, and the possibility of a deadly infection. The probability of serious injury or illness occurring as a result of this potential issue is unlikely, however, likelihood is greater for immunocompromised patients. To date, Datascope / Maquet Getinge has not received any complaints, nor have any adverse events been reported resulting in serious illness or injuries caused by the Reinforced Introducer Set for Maquet 7 Fr., 7.5 Fr.
BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
Affected consignees were notified by letter delivered via FedEx on October 19, 2017. After CTI expanded their recall in March 2018, Getinge accordingly alerted additionally affected consignees by letter delivered via FedEx on April 5, 2018. The recall letter advised customers of the issue and referenced the CTI recall notification, which was included as an attachment to Getinge's communication. End-users were instructed to examine their inventory to determine if they had any of the affected catalog/lot numbers. Any affected product is to be immediately quarantined and returned to Getinge by contacting Customer Service at 1(888) 627-8383 (option 2, then option 2 again), Monday through Friday, 8AM-6PM. In addition, customers were asked to complete a response form to acknowledge receipt of the notification, and return to Getinge. After communications with some end-users who were concerned about maintaining inventory of custom tubing kits, Getinge revised their recall strategy to include an option for replacement of the recalled Better Bladder device. Customers who wished to receive a replacement device will be provided with the device and a notice which must be affixed to the recalled kit. This will ensure that at time of use, it will be obvious to the user that the Better Bladder device inside the kit must be switched out with the replacement device prior to use. The removed recalled Better Bladder device must then be sent back to the recalling firm, Getinge. This information was communicated to customers via telephone call or visit on 4/20/18, and a summary of the communication was sent as an amended recall notification to customers who stated during the phone call that they still had recalled product on 4/21/18. Maquet/Getinge Customer support may be reached at 1(888) 627-8383 (press option 2, then option 2), Monday through Friday, 8AM-6PM.
Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
Maquet/Getinge issued a recall letter on February 21, 2018 to affected customers, via FEDEX with confirmation of delivery, to notify them of the fact that the IFU is missing the Contraindications section and to provide the missing information. Affected customers are instructed to examine their inventory immediately to determine if they have affected product. An Addendum to the Mega IAB Catheter IFU, containing the Contraindications, is provided as an attachment in the recall letter. It is suggested that affected customers post copies of the Addendum near all affected lot numbers of Mega IAB Catheters. Customers are provided with Maquet/Getinge contact information should their facility require a full copy of the correct Mega IAB Catheter IFU. Lastly, affected customers are instructed to complete and sign a response form, acknowledging that they have received the notification, and return the form to Maquet/Getinge.
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six
There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
On 7/27/17, an Urgent Safety Alert was issued to customers of the Cardiovascular Procedure Kit with LN130B Over-pressure Safety Valves. The safety alert instructed customers to perform the following: Please examine your inventory immediately to determine if you have unused kits of the batch numbers listed. If so, please follow the recommended actions outlined in the attached Terumo Cardiovascular Systems Urgent Safety Alert. It is possible that custom tubing kits with the affected valves may have already been used without issue. Customers were instructed to test the valve prior to use. The notice was sent to customers again on 10/3/17 and 12/12/17. On 1/11/18, Urgent Medical Device Recall letters were sent to customers. The letters included the following instructions: Terumo CVS now recommends removal of any remaining product from your inventory. A review of our records indicates that you have received the following Maquet/Getinge Custom Tubing Kit batch numbers affected by the Terumo Cardiovascular Systems Medical Device Recall (refer to information provided in the table below). Please examine your inventory immediately to determine if you have unused custom tubing kits of the batch numbers listed. If so, please remove the affected products, quarantine them and follow the instructions for returning the product to Maquet/Getinge for full credit. It is possible that custom tubing kits with the affected valves may have already been used without issue. The Terumo Cardiovascular Systems Medical Device Recall affects the Custom Tubing Kit with LN130B Over-pressure Safety Valve distributed by Maquet/Getinge having lot/batch numbers listed above; no other product lot/batch numbers that were delivered to you are affected. Instructions for returning affected product: 1. Review this notice and Terumos Medical Device Recall Notice (attached). 2. Ensure that all users (i.e. perfusionist, operating room staff and biomedical staff) receive notice
SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK Product Code/Part Number: 0684-00-0576-01U is a cardiac assist device which support the heart's left ventricle by increasing coronary perfusion and reducing the work of the left ventricle.
Maquet/Getinge is initiating a voluntary product removal involving four lot numbers of SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK since during internal pressure (leak) testing of the SENSATION PLUS 8Fr. 50cc, IABC, failures related to the tip seal leak were identified.
Getinge notified their customers with a recall letter/return response form via Fed Ex on 4/12/2017. Getinge notified their customers again through an expansion on 10/16/2017.
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588
There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.
Urgent Safety Alert notifications were sent to customers on 3/11/16. The notices included the following instructions for customers: Please examine your inventory immediately to determine if you have the lot/batch numbers listed. If so, please following the recommended actions outlined in the attached Terumo Cardiovascular Systems Urgent Safety Alert. URGENT: Please complete attached Customer Response Form on page 3, to acknowledge that you have received the Terumo Cardiovascular Systems Urgent Safety Alert. Please fax the completed Customer Response Form to 1-973-396-3607 or send via email to fieldactions@maquet.com.
MEGA 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit, STATLOCK & APA
It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK Sheath Stabilization device for Percutaneous Sheath Introducer (Vendor PN 2403097-1405R) was erroneously packaged with the Mega and Sensation Plus IAB Catheter Kits instead of the IFU for the STATLOCK Catheter Stabilization device for IAB catheters (Vendor PN 24030905-1406R).
Maquet Inc sent an Urgent Medical Device Field Correction Letter/Response Form dated 5/13/2016 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.
Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubi
A complaint was received on January 1, 2017 stating the pigtail on line 2 of the oxygenator was assembled to the port where the yellow cap and the clear cap remained on the center port.
Maquet Inc. was notified by their customer on January 1, 2017. This was a reverse notification. The one impacted customer said they will not return the product since they can easily correct the pigtail connection before use. For further questions regarding this recall, please call (973) 709-7442.
Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is
Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of endotoxin that exceeded the regulatory limits.
Maquet sent via express mail and hand delivered a recall letter and response form dated May 9, 2016 to their sole customer.
LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group
During label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 40 cc Intra-Aortic Balloon Catheter.
Maquet Inc.is sued an Urgent Medical Device Recall Letter/ Fax Back Form dated August 11, 2014. Customers are asked to quarantine the affected product and upon return they will be provided with an exchanged unaffected product. The attached form should be completed an returned to Maquet Inc. Questions can be directed to Maquet Technical Support at (888) 627-8383 - Press option "3" followed by option "1" Monday through Friday between the hours of 8 am and 5 pm (EST).
CS100 Intra-Aortic Balloon Pump.
Certain MAQUET/Datascope Intra-Aortic Balloon Pumps (IABP) have the potential to experience display related issues. Although the IABP continues to deliver therapy to the patient, display related issues may cause the user to be unable to view the IABP on the information screen.
Medical Device Recall Letters were sent to Hospital Administrators beginning May 10, 2010 by overnight mail. Customers with questions are directed to contact your local Sales/Service Representative or the company representative at 973-244-6314.
Low-Level Output Cable. The device is used to allow the information displayed on the Intra-aortic balloon pump (IABP) to be displayed on a separate patient monitor.
Non-functioning cable: the Low-Level Output Cable when connected to a Datascope Intra-aortic Ballon Pump (IABP) and patient monitor does not provide a signal to the patient monitor.
An "Urgent Medical Device Recall" letter dated February 4, 2009 was delivered to affected consignees by Datascope Field Representatives. Direct questions to your local Sales/Service Representative or call the Datascope Corporation at 1-973-244-6314.
Datascope, Panorama Patient Monitoring Network; Panorma Telepack 608;Software Versions 8.1.X, 8.3, 8.3.1, 8.4.1, and 8.5.X, Part Number: 0998-00-0191-04, Datascope Corp., Mahwah, NJ
Display problems: If an ECG cable, which has been damaged due to the ingress of liquid or by mechanical trauma, is utilized with the Telepack, it may cause the Telepack to switch between the 3-lead and 5 lead-input modes. During the switching process, the digital heart rate displayed at the Panorama Central Station will be frozen, and subsquent arrthymia alarms will not be announced.
Urgent Product Field Correction notices were sent to hospital administrators on October 9, 2007, by certified mail, return receipt requested. The letter describes the scenario that causes the problem and its remediation It also describes how the software upgrade will fix the problem and alerts hospitals that a Datascope Service Representative will be contacting them to arrange for the upgrade.
Precision Bipolar Device ClearGlide EVH Small (endoscopic vessel harvesting system) The kit included three Precision BiPolar Devices, an Optical Vessel Dissector, a Small Ultra Retractor and a Vessel Dissector. Datascope Cardiac Assist Sterile R Manufactured for: Datascope Cardiac Assist 15 Law Drive Fairfield, NJ 07004
Datascope has experienced a higher than usual number of reports involving the Precision Bipolar Device. Reports include the locking or sticking of the buttons of the device which operate the jaws, particularly when a side load is placed on the shaft of the device.
Letters were sent to all hospitals, (contact: Hospital Administrators) the week of May 7, 2007 (certified mail, Return Receipt requested) with Urgent Medical Device Field Correction. The letter requests that all potential users of the devices at the institution be mdae aware of the situation. The letter instructs clinicians what to do if they experience problems with locking buttons of the Precision Device and also if the device is clamped closed on a vein branch and cannot be opened. Institutions are also requested to sign and return a postal card acknowledging receipt of the Field Correct notification and Datascope provides telephone numbers for customer service.
HemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch. Product Catalog Numbers: HEK06/75CPUT; HEK08/75CPUT; HEK14/75CPUT; HEK08/120CPUT; HEK10/75CPUT; HEK25/100CPUT; HEK12/75CPUT; HEK10/150CPUT.
Water permeability of the patch is out of specification.
Recall letters were sent to the customers via US Mail return receipt on 12/30/2003.