EXCOR Pediatric VAD Blood Pump PU Valves
Berlin Heart is recalling EXCOR Pediatric VAD Blood Pump PU Valves due to an expiration date mismatch that could delay surgical procedures.
Check the expiration dates on both the inner and outer packaging of your blood pump valves. If the dates do not match, contact Berlin Heart for further instructions and do not use the affected device.
Why it was recalled
Berlin Heart is recalling EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves due to a discrepancy between the expiration dates printed on the inner and outer packaging. This mismatch may cause confusion regarding the sterility or integrity of the device, potentially leading to delays in surgical procedures.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
- UPC
- 04260090040102, 04260090040126
- Recall #
- Z-2320-2026
Where it was sold
Distributed nationwide.
Official source
Editorial summary by Recall Canary · last updated 2026-06-06 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification