Reported Jun 17, 2026 · Ongoing
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF:…
Berlin Heart GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BERLIN HEART GMBH · Wiesenweg 10 · Berlin, N/A · N/A
Is this the product you have?
- EXCOR Pediatric Ventricular Assist Device (VAD)
- System Blood Pump PU Valves10 ml
- REF
P10P-00130 ml
- REFP30P-001x01
- Lot codes and dates
2 of 2 products · 3 lot codes
Recalled lot codes, grouped by product number REF UDI-DI serial number P10P-0010426009004010222307142230709
P30P-001x01042600900401262230254
- Amount recalled
- 3
Where it was sold
Why it was recalled
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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