Recall Z-1557-2025— Abbott Medical
Class II · Ongoing
Class II FDA medical device recall by Abbott Medical, initiated 2025-02-15. FDA's recall record names no specific 510(k) clearance for this event. 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: Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure..
- Recalling firm
- Abbott Medical
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-02-15
- Firm location
- Sylmar, CA, United States
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.