EXCOR Pediatric Ventricular Assist Device recall (BERLIN HEART GMBH)
Medical deviceClass IIOngoing
Summary: BERLIN HEART GMBH is recalling EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01. Reason: Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
What is being recalled
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
Why
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of MA, SC. (states named: Massachusetts, South Carolina)
How to tell if yours is affected
REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2320-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 24, 2026 |
| Reported | June 17, 2026 |
| Company | BERLIN HEART GMBH |
| Company location | Berlin, N/A, Germany |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 3 |
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