Berlin Heart Gmbh Wiesenweg 10 Berlin Germany: Ventricular (assist) Bypass
Recall Summary Berlin Heart is recalling certain EXCOR Pediatric Ventricular Assist Device blood pumps because the expiration date printed on the inner package doesn't match the correct expiration date on the outer package. This mismatch could cause delays when surgeons need to use these devices for pediatric patients. The recall affects units distributed across the United States.
- Recalling firm
- BERLIN HEART GMBH Wiesenweg 10 Berlin Germany
- 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 III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-24
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of MA, SC.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/25e81e89-a630-4fbf-86c7-5b3167fb39b0