BERLIN HEART Recalls
2 recalls on record · May 31, 2023 to June 17, 2026 · Medical Devices
Recalls by year
23
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 17, 2026Medical DevicesFDA
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
Hazard: Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
May 31, 2023Medical DevicesFDA
BERLIN HEART GMBH recalls EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump
Hazard: There is a potential for a disruption in one or more of the triple layer membranes of the ventricular assist device. Recall occurred in 2018, and was retrospectively reported.