CLASS II ONGOING Device recall · Reported 23 Apr 2025 · FDA Enforcement Report

Aveir DR Leadless Pacemaker (LP) Ventricular Device recalled

Abbott Medical is recalling Aveir DR Leadless Pacemaker (LP) Ventricular Device, distributed nationwide in the US. The recall was initiated on 15 Feb 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: LSP202V UDI-DI code: 05415067040725 Serial Numbers: 1357831, 1357869, 1357885, 1357894, 1357895 Model Number: LSP112V UDI-DI code: 05415067034472 Serial Number: 1357956

Quantity recalled6 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1557-2025
FDA event ID: 96411
Recalling firm: Abbott Medical, Sylmar, CA
Classification: Class II
Status: Ongoing
Recall initiated: 15 Feb 2025
FDA classified: 14 Apr 2025
Reported: 23 Apr 2025
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Temperature Abuse
Device type: Pacemakers & Defibrillators

Timeline

15 Feb 2025	Recall initiated by company
14 Apr 2025	Classified by FDA	+58 days
23 Apr 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Florida South Carolina West Virginia

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Model Number: LSP202V UDI-DI code: 05415067040725 Serial Numbers: 1357831, 1357869, 1357885, 1357894, 1357895 Model Number: LSP112V UDI-DI code: 05415067034472 Serial Number: 1357956

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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