Class 2 Device Recall Aveir DR Leadless Pacemaker (LP) Ventricular Device

• Date Initiated by Firm: February 15, 2025
• Date Posted: April 14, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1557-2025
• Recall Event ID: 96411
• PMA Number: P150035S003
• Product Classification: Leadless pacemaker - Product Code PNJ
• Product: Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantation and use of an Aveir Leadless Pacemaker (LP) within the targeted chamber(s) of the heart for monitoring a patient s heart rate and providing rate responsive bradycardia pacing therapy to regulate heart rate.
• Code Information: Model Number: LSP202V UDI-DI code: 05415067040725 Serial Numbers: 1357831, 1357869, 1357885, 1357894, 1357895 Model Number: LSP112V UDI-DI code: 05415067034472 Serial Number: 1357956
• Recalling Firm/ Manufacturer: Abbott Medical; 15900 Valley View Ct; Sylmar CA 91342-3577
• For Additional Information Contact: Ms Alicia Swanson; 408-845-3427
• Manufacturer Reason for Recall: Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.
• FDA Determined Cause: Process control
• Action: On 02/15/2025, the firm communicated with the implanting/following physicians via phone call and in-person meeting. Customers were informed that a subset of Aveir Leadless pacemaker devices manufactured in January 2025 had experienced a departure from manufacturing baseline parameters due to incorrect equipment set-up. As a result of this issue, the glass insulator separating the battery from the electronics may have microcracks that could lead to the reduction in longevity of the device and loss of functionality. Customers are instructed to: Recognizing that each patient requires individual consideration, Abbott recommends: "Consideration of device retrieval and/or replacement (with a leadless or transvenous device), particularly if your patient is pacemaker dependent. "Follow-up actions should consider evaluation of individual patient needs, disease states, and co-morbidities. "Timing of device replacement should depend on the patient s clinical characteristics. Customer were also instructed to acknowledge the customer notification by returning Acknowledgement Form to crmcommercialcompliance@abbott.com Additional notification of customers were on 02/15/2025 and 02/27/2025 via email.
• Quantity in Commerce: 6 devices
• Distribution: Worldwide - U.S. Nationwide distribution in the states of FL, SC, and WV and the country of Spain. There were five (5) LSP202V devices distributed within the United States (3 in FL, 1 in SC, 1 in WV) that are impacted by this issue, two (2) of which were implanted, see Attachment A.3 for list of serial numbers. There is 1 LSP112V device that is impacted by this issue, but this was distributed outside of the United States. See Attachment A.4 for list of OUS serial numbers.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = PNJ