Device recall
Z-1618-2023: EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml…
FDA device recall · Class I · BERLIN HEART GMBH
Key facts
| Recall number (Z-number) | Z-1618-2023 |
|---|---|
| Recall event | 92132 |
| Product | EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50 ml blood pump); P60P-001 (60 ml blood pump). Recall occurred in 2018, and was retrospectively… |
| Product code | DSQ |
| Recalling firm | BERLIN HEART GMBH |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 6, 2024 |
| PMA numbers | P160035 |
| FEI number | 3004582654 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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