Aveir DR Leadless Pacemaker (Abbott) – Battery Temperature Risk (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Abbott Medical
Lot Codes / Batch 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
Products Sold
Model Number: LSP202V UDI-DI code: 05415067040725 Serial Numbers: 1357831, 1357869, 1357885, 1357894, 1357895 Model Number: LSP112V UDI-DI code: 05415067034472 Serial Number: 1357956
Abbott Medical is recalling Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP due to Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failu. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026