Brand
BERLIN HEART GMBH
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for BERLIN HEART GMBH and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-05-31FDA-DeviceClass IEXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50 ml blood pump); P60P-001 (60 ml blood pump). Recall occurred in 2018, and was retrospectively reported.
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.
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