Medical Device Recall: Z-1557-2025

FDA Recalls dataset · Firm: Abbott Medical · Status: Open, Classified

Recall Action Class: N/A Date Initiated: 2025-02-15 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-1557-2025.

Recall Res Number
Z-1557-2025
Recalling Firm / Manufacturer
Abbott Medical
FEI Number
2017865
Recall Status
Open, Classified
Recall Classification
N/A
Date Initiated
2025-02-15
Date Posted
2025-04-14
Date Terminated
N/A
Product Code
PNJ
Event Number
96411
Product Quantity
6 devices
Product Description 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.
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.
Action Details 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.
Distribution Pattern 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.
Code Information / Serial Numbers Model Number: LSP202V UDI-DI code: 05415067040725 Serial Numbers: 1357831, 1357869, 1357885, 1357894, 1357895 Model Number: LSP112V UDI-DI code: 05415067034472 Serial Number: 1357956

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