Acist Medical Systems Recalls
Showing 1-9 of 9 recalls
ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi System.
Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. Further testing indicated that pieces (>200 micron) of damaged o-ring had the potential to be flushed out of the catheter. ACIST is confirming the source of the failure mode to assure the quality and reliability of the Kodama catheter. There have been no related field reports related to this incident, nor any evidence or report of patient injury or adverse health consequence.
The firm, ACIST, sent an, "URGENT: MEDICAL DEVICE RECALL" letter and response form dated Jan 22, 2021 to customers on Jan. 22, 2021. The letter describe the product, problem and actions to be taken. The customers were instructed to do the following: to complete all of the steps outlined below and return the completed Recall Response Form to Stericycle by e-mail: acistmedical8961@stericycle.com or fax to 877-576-9366. 1. Check your inventory of Kodama HD-IVUS Catheter 2. Record quantities of each lot in the Response Form 3. Remove the affected lots from your inventory. 4. Use the enclosed, prepaid return label to return your affected product including a copy of the response form with the product. If you need additional labels, please contact Stericycle at 877-576-9382. If you have received any reports of illness, injury or other health consequence related to the use of product please contact Customer Support: Customer.Support@acistmedical.com Please forward this notice to those who need to be aware within your organization. If you have any further questions or concerns, please contact Stericycle at 877-576-9382.
ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only, Made in Mexico. The manifold body is identical in the BT2000 and CPT2000 kits. The BT2000 and CPT2000 kits facilitate connection to, and delivery of, either contrast or saline into the patient via a coronary catheter (not provided by ACIST). To be used for the controlled infusion of radiopaque contrast media for angiographic procedures
Reports related to ingress of air into the manifold.
Acist sent an Urgent Medical Device Recall letter dated December 21, 2015, via e-mail to all affected consignees. The letter was addressed to Distribution Partner or Cardiac Cath Lab / Material Manager in the USA. In Europe, the letter was addresses to Purchasing Department. The letter described the problem and the product involved in the recall. Advised consignees to return affected units and to complete and return the Medical Device Recall Form. Distributors were further advised to send the recall letter to their customers. For questions or concerns, contact in US, ACIST Customer Service 1-888-670-7701 or your ACIST Sales Representative. Europe Direct contact ACIST Europe Customer Service +44 (0) 845 548 12 80 or contact your ACIST Sales Representative, Europe Indirect contact ACIST Europe Customer Service +31 45 750 70 25 or contact your Distributor. Distributors contact: ACIST Europe BV, Office: +31 (0)45 750 7015, Mobile: +31 (0)6 233 648 46.
ACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
ACIST Medical Systems is issuing a voluntary recall notice for three specific lots of BT2000 Automated Manifold Kits. For these specific lots, ACIST has received field reports related to ingress of air into the manifold body. This has been detected by the Air Column Detect Sensor halting the injection, and normally replacement of the BT2000 Automated Manifold Kit is necessary in order to proceed w
ACIST Medical Systems sent an Urgent Medical Device Recall letter dated March 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter advised customers that if they had inventory of any of the lots under the scope of the recall, to discontinue use or further distribution of the product. If you possess inventory containing any of the lot numbers listed above, please discontinue use or further distribution of these products. Please return this inventory to ACIST. Upon receipt of the returned BT2000 Automated Manifold Kits, ACIST will arrange for a shipment of replacement kits at no charge. To order additional or immediate replacement product, please contact BRACCO customer service at 1-877-BRACCO9 (1-877-272-2269), option 1. Please also complete and return the enclosed Medical Device Recall Form (see enclosure). Even if you do not possess any of the affected product in your inventory, the form needs to be completed and returned, indicating that you have no remaining units containing these lot numbers in your inventory.
ACIST Automated Manifold Kit , REF Model BT2000, SKU # 014613, Sterile R, Made in Mexico, Manufacturer; ACIST LMedical Systems Inc, 7605 Fuller Road, Eden Prairie, MN .55344. The automated manifold kit is comprised of an injection manifold, a pressure transducer cartridge, a check valve, tubing (low, high and peristaltic pump), and a saline spike. This kit is designed for exclusive use with the ACIST CMS2000, E2000 Voyager and CVi models of Angiographic Contrast Delivery Systems. This kit is f
ACIST Medical Systems initiated a recall due to an increase in the incidence of field reports related to a bulge on the side and/or leaks in the bond of the 2.5 high-pressure tubing of BT2000 kits during a procedure which can result in unsatisfactory performance of the ACIST BT2000 Automated Manifold Kit.
Consignees were sent on 5/11/09 a ACIST Medical Systems "Urgent: Medical Device Recall" letter dated May 11, 2009. The letter described the problem and the product. It advised consignees to discontinue the use or further distribution of the recall product and to return the inventory and the enclosed "Medical Device Recall Form". Please use the enclosed form with firms address: 7905 Fuller Rd, Eden Prairie, MD 55344. Additional questions please contact the firm at 1-877-272-2269, option 1.
ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Infinix-i cardiovascular X-ray system, Part Number 700318-002. The ACIST injection system is an angiographic injection system used in interventional cardiology, radiology, and vascular surgical procedures. The ACIST injection system supplies radiopaque contrast media to a catheter at a user-determined variable flow rate and volume which can be instantaneously and continuously varied. Manufactured by: ACIST Medical Syst
Multiple Injections may result. It has been determined that when using the ACIST CVi Angiographic Injection system to synchronize with the Toshiba Infinix -i cardiovascular x-ray system there is an injection scenario that may result in multiple injections of contract media when one injection was intended.
ACIST is distributing an Urgent Medical Device Correction letter, dated November 10, 2008, to affected customers. The letter describes the issue and the scenario when the issue to occur, instructs them to discontinue use of the synchronized mode between the ACIST Angiographic Injection System model CVi and the Toshiba Infinix-i X-ray fluoroscopic system by disconnecting the interface cable immediately. The letter states that ACIST is working with Toshiba to resolve this issue. A response form is asked to be returned either by fax, e-mail or mail. If there are any questions, they should be directed to either ACIST at 952-995-9300 or local Sales Reps or Clinical Applications Specialist.
ACIST" BRACCO, AT P54 AngioTouch Kit , SKU # 014644, Sterile EO Manufacturer; ACTB Medical Systems, Inc. 7905 Fuller Road, Eden Prairie, MN 55344, Made in Mexico. Catalogue No: 800608-013 Intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
Some of the sterile package seals of AT P54 AngioTouch Kit were breached. Breached package seals could compromise product sterility, which could potentially lead to patient infection.
Consignees were sent a "Urgent: Medical Device Recall" letter dated July 9. 2008. The letter addressed to "Manager" described the Proben and product. The letter advised customers that if they had inventory of any of the lots under the scope of the recall, to stop further distribution of that product and immediately cease use of the product. The letter listed the applicable lots and asked customers to verify their inventory against the list. Any inventories matching the lots on the recall list were to be checked on the provided form and the quantity recorded. They were instructed to return the product to ACIST using the provided Air Bill number along with the form, signed and dated. The letters were sent July 10, 2008.
ACIST Multi-Use Syringe Kit, Model A2000; SKU # : 014612; labeled as STERILE; Manufactured: Acist Medical Systems, Inc., 7450 Flying Cloud Drive, Suite 150, Eden Prairie, MN 55344, USA. Catalogue No: 800061-003. (The multiple use A20000 syringe kit is comprised of a terminally sterilized syringe barrel and a contrast spike assembly)
Syringe Fracture: the syringe may be fractured, causing contrast to be sprayed from syringe fracture.
The Urgent Medical Device Recall letter was sent by certified mail to all U.S. base customers on 10/3,4/07. Customers were advised to stop distribution of the product and immediately cease use of the product. Recalled product is to be returned using the FedEx Airbill that was enclosed with the recall letter. Customers were to complete the enclosed "Device Recall Response" form even if they did not have any impacted kits in inventory.
ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Contrast Management Systems (CMS2000) and E2000 Voyager Units)
Some of the automated manifold's 2.5 inch high-pressure lines for radiopaque contrast media, used in angiographic procedures, have separated where they are bonded to the manifold body of the device allowing contrast media to leak.
The consignees were sent letters dated 10/2/03 which requested that the product be returned.
AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System.
Some of the sterile product packages were inadequately sealed prior to sterilization and as a result the package contents may not be sterile.
Each consignee was contacted by telephone and asked to return unused kits with the affected lot number.