Recall Z-2320-2026

Recall number
Z-2320-2026
Event number
98797
Firm
BERLIN HEART GMBH Wiesenweg 10 Berlin Germany
Firm FEI
3004582654
Product code
DSQ
Status
Open, Classified
Initiated
2026-04-24
Posted
2026-06-05
Root cause
Error in labeling

Product#

EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01

Reason for Recall#

Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.