Recall Z-1557-2025 ยท PNJ Leadless Pacemaker
Abbott Medical
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 rat
| Date | Apr 14, 2025 (initiated Feb 15, 2025) |
| Status | Open, Classified |
| Reason | Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure. |
| Root cause | Process control |
| Action | 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 individua |
| Quantity | 6 devices |
| 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 s |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.