Abbott Recalls
Showing 1-8 of 8 recalls
Amplatzer Steerable Delivery Sheath
Instructions for use were updated.
Impacted consignees will receive a notification letter via registered mail, from an Abbott field representative, or via phone call and a follow-up email where in-person communication is not possible. The product is not being removed from the field and does not need to be returned. The recalling firm is providing additional instructions to reduce the potential for air ingress.
FIRMap" Catheter, 60mm Basket
Incorrect product labeling.
The firm sent out a "MEDICAL DEVICE RECALL" notification letter dated 04/28/2022 via hand delivery to the US customers. OUS consignee notification is via hand delivery. A copy of the English version of the OUS letter is attached and this letter was translated into the appropriate languages for delivery. The letter instructs the consignee to stop using the remaining inventory, complete and return the acknowledgement form by email: EPCcompliance@abbott.com, and return all unused devices. Should you have questions about this issue, please contact your local Abbott Representative or Abbot Support at 1-888-655-3500 (Option 2) (U.S.), 8:30 a.m. - 5:30 p.m. Central Time Monday through Friday.
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in length instead of the intended 5 cm in length.
The firm initiated the recall by telephone on 16 NOV 2021 followed by a letter emailed on 18 NOV 2021. The letter explained the problem and requested the return of the affected devices.
Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads.
Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously programmed energy level and the user will not be alerted that the selected value was not retained.
On 02/28/2020, the frim sent all US consignees an "IMPORTANT MEDICAL DEVICE CORRECTION" letter via USPS three to five-day ground service. The customer notification informed customer that they had recently deployed a Patient Care System (PCS) programmer software that contained an anomaly that may result in specific programming changes not being stored in the device. The Recalling Firm explained that when using the affected programmer software to make certain programming changes, the changes may appear to have been successfully programmed but the device could remain at previously programmed settings. This issue can occur only if changes to tachycardia therapy Tilt or Waveform (monophasic/biphasic) settings are made and therapy energy value are modified from nominal using the new programmer software. The customer notification also informs customer of Patient Management Recommendations: The Recalling Firm has developed an updated programmer software version which will correct this issue. This solution does not present additional risks to patients and no intervention is needed for patients. The Recalling Firm will update the programmer software in the coming days. For any questions contact your representative or Technical Support at 1-800-722-3774 (U.S.).
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
The recalling firm issued letters dated 3/24/2022 on 3/24/22 via hand-delivery. The letters explained the issue, the impact and associated risks, and the steps to reduce risk. The steps included not using any of the remaining inventory of the affected lots listed in Appendix A, complete and return the accompanying Acknowledgment Form, and return all remaining unused affected devices to the recalling firm. The consignee is informed their Abbott representative can assist in returning these devices and obtaining replacements. The notice is to be forwarded to anyone within their organization who may need to be notified and a copy of the notice should be kept along with the completed Acknowledgment Form for their records.
Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.
Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm. Outflow graft occlusions can result in serious adverse events such as hemodynamic compromise, thrombus, and death.
Customers were notified via an Important Medical Device Advisory letter, dated 04/05/2018, that the firm has received reports of outflow graft twist occlusions in the HeartMate 3 (HM3) Left Ventricular Assist System. As a result, patients whose devices experience this issue will experience a persistent low flow alarm. Outflow graft twist occlusions can result in serious adverse events such as hemodynamic compromise, thrombus, and death. Physicians managing patients that will be implanted or already implanted with HM3 devices should follow the recommendations provided in the letter. Additionally, physicians managing patients that exhibit a persistent low flow alarm should determine patient care recommendations based on each unique clinical case. Questions should be directed to customers' local Abbott MCS Clinical Specialist or MCS HeartLine 1-800-456-1477. The firm issued a press release, dated 05/04/2018, notifying physicians about a field corrective action related to the HeartMate 3 Left Ventricular Assist Device (LVAD). Outflow graft twisting could occur post-implant in the HeartMate 3 LVAD, resulting in a persistent low flow alarm that may signal a potential safety risk to patients, such as low blood flow or clotting. No devices are being recalled from patients or hospitals as a result of the corrective action, and the recommendations made by the firm remain in place for physicians managing patients implanted with HeartMate 3. On 10/17/2018, the firm mailed an Urgent Medical Device Correction notice to consignees informing them that the Outflow Graft Clip was now available. The Outflow Graft Clip is intended to be used with all new patient implants and may be used on patient cases where an Outflow Graft twist is confirmed and surgical intervention is required. All HM3 implanting centers are required to be trained on the proper attachment of the clip prior to use of the clip.
St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for card
The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.
Abbott sent an Important Medical Device Correction letter dated November 20, 2018 to affected customers. The letter identified the affected product, problem and actions to be taken. Should you have questions about this issue, contact your local Abbott Representative or Abbott Support at 1-800-727-7846 (Opt3) (U.S.), 8:30am - 5:30pm Central Time Monday thru Friday.
TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usage: is a multi-electrode irrigated catheter with a deflectable tip designed to allow electrophysiological mapping of the heart and, when connected to an RF generator, to deliver radiofrequency current to the catheter tip electrode for the purpose of ablation.
High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter
The firm began notifying their consignees by letter on 05/22/2020. The notification reported the high rate of reported complaints for loss of contact force information while using the product, the risk to patient, and recommendations to avoid contact force failures.