FDA DevicesClass II
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ...
Published: June 17, 2026Recall ID: Z-2320-2026Category: devicesCountry: US
Reason for Recall / Hazard
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
Product Description & Identification
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
Additional Source Details
| Field | Value |
|---|---|
| City | Berlin |
| State | N/A |
| Event id | 98797 |
| Address 1 | Wiesenweg 10 |
| Address 2 | N/A |
| Code info | REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254 |
| Postal code | N/A |
| Report date | 20260617 |
| Product type | Devices |
| Product quantity | 3 |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260424 |
| Initial firm notification | Letter |
| Center classification date | 20260605 |
Overview
- Recalling FirmBERLIN HEART GMBH
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of MA, SC.