Recall Z-2320-2026— BERLIN HEART GMBH

Name: FDA recall Z-2320-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-24

Class II · Ongoing

Class II FDA medical device recall by BERLIN HEART GMBH, initiated 2026-04-24. FDA's recall record names no specific 510(k) clearance for this event. 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..

Recalling firm: BERLIN HEART GMBH
Classification: Class II
Status: Ongoing
Initiated: 2026-04-24
Firm location: Berlin, N/A, Germany

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.