Recall Z-2320-2026 ยท DSQ Ventricular (Assist) Bypass
BERLIN HEART GMBH
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
| Date | Jun 5, 2026 (initiated Apr 24, 2026) |
| Status | Open, Classified |
| Reason | Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures. |
| Root cause | Error in labeling |
| Action | On 4/24/2026, recall notices were emailed to customers who were asked to do the following: 1) Segregate and discontinue use of any affected unused product. 2). Notify all appropriate personnel within your organization who need to be aware of this recall. 3) If any affected devices have been transferred to another facility or customer, promptly forward this notification to those accounts. 4) Firm will provide replacement products for the affected mislabeled devices and will issue a return shipping label so affected unused products may be returned through the Return Goods Authorization (RGA) pr |
| Quantity | 3 |
| Distribution | US Nationwide distribution in the states of MA, SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.