BERLIN HEART GMBH recalls EXCOR Pediatric Ventricular Assist Device
- Recalling company
- BERLIN HEART GMBH
- Product
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Apr 24, 2026
- Reported
- Jun 17, 2026
- Distribution
- US Nationwide distribution in the states of MA, SC.
- Status
- Ongoing
- Quantity
- 3
- Lot / codes
- REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254
- Company location
- Berlin, N/A
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2320-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2320-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.