The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1557-2025·Announced 2025-04-23

Abbott Aveir DR Leadless Pacemaker Recalled for Battery Failure Risk

Abbott Medical is recalling specific Aveir DR Leadless Pacemaker devices due to manufacturing exposure to higher-than-normal temperatures that may cause premature battery failure.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a critical life-sustaining implantable device with a known risk of premature battery failure, which poses a serious risk of harm to patients even though no illnesses or injuries have been reported to date.

Plain-English summary

Abbott Medical is recalling certain Aveir DR Leadless Pacemaker (LP) Ventricular Devices due to a manufacturing issue. The affected devices may have been exposed to higher than normal temperatures during manufacturing, which may result in premature battery failure.

Five LSP202V devices were distributed in the United States (3 in Florida, 1 in South Carolina, 1 in West Virginia), of which two were implanted. One LSP112V device was distributed outside the United States. The devices have been identified by their specific serial numbers.

Patients with implanted devices should contact their healthcare provider for evaluation and guidance. Abbott Medical and the FDA are notifying healthcare facilities and affected patients. No deaths or injuries have been reported as of the issuance of this recall.

The recalled product

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)…
Manufacturer
Abbott Medical
Category
Medical Device — Cardiac / Pacemaker
Hazard
Affected units
6

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Model Number: LSP202V UDI-DI code: 05415067040725 Serial Numbers: 1357831
  • 1357869
  • 1357885
  • 1357894

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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