# FDA recall Z-1557-2025

> **Abbott Medical** · Class II · device recall initiated 2025-02-15.

## 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.

## 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.

## 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.

## Key facts

- **Recall number:** Z-1557-2025
- **Recalling firm:** Abbott Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-15
- **Report date:** 2025-04-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sylmar, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1557-2025

## Citation

> AI Analytics. FDA recall Z-1557-2025. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-1557-2025. Source: US FDA. Licensed CC0.

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