Drug recall
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF…
FDA recall event 98797 · Class II · BERLIN HEART GMBH
Key facts
| Event ID | 98797 |
|---|---|
| Recall numbers | Z-2320-2026 |
| Recalling firm | BERLIN HEART GMBH |
| Product type | Devices |
| Products | EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures. |
| Initiation date | Apr 24, 2026 |
| Report date | Jun 17, 2026 |
| City | Berlin |
| Country | Germany |
| FEI number | 3004582654 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: