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BERLIN HEART GMBH recalls EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x
Recalled June 17, 2026 · FDA recall Z-2320-2026 · BERLIN HEART
Hazard
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures. · FDA Class II
Units
3
Sold at
US Nationwide distribution in the states of MA, SC.
Description
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
Product
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
Manufacturer(s)
BERLIN HEART GMBH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →