Recall Z-1618-2023— BERLIN HEART GMBH
Class I · Terminated
Class I FDA medical device recall by BERLIN HEART GMBH, initiated 2018-05-18, terminated 2024-06-06. FDA's recall record names no specific 510(k) clearance for this event. Product: EXCOR 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.. Reason: 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..
- Recalling firm
- BERLIN HEART GMBH
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2018-05-18
- Terminated
- 2024-06-06
- Firm location
- Berlin, N/A, Germany
Product description
EXCOR 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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.