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Aveir recallZ-1557-2025 · Abbott Medical · initiated Feb 15, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Abbott Medical or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.

FDA root cause category: Process control

What the company is doing

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 [email protected] Additional notification of customers were on 02/15/2025 and 02/27/2025 via email.

Recall details

Recall number
Z-1557-2025
Status
Open, Classified
Initiated by the company
Feb 15, 2025
Posted by the FDA
Apr 14, 2025
Recalling firm
Abbott Medical
Quantity
6 devices
Product code
PNJ
FDA submissions
P150035S003
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.

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.

Code information (models, lots, 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

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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