Device recall
Z-1557-2025: Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code…
FDA device recall · Class II · Abbott Medical
Key facts
| Recall number (Z-number) | Z-1557-2025 |
|---|---|
| Recall event | 96411 |
| 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… |
| Product code | PNJ |
| Recalling firm | Abbott Medical |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P150035, P150035S003 |
| FEI number | 2017865 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database