Class II

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

BERLIN HEART GMBH · April 24, 2026

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.

Distribution

US Nationwide distribution in the states of MA, SC.

States Affected

NATIONWIDE

Quantity Affected

3

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2320-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

BERLIN HEART GMBH Medical Device Recall: EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01 | SafeCheck