Berlin Heart GmbH
Berlin, DE
BERLIN HEART GMBH appears in FDA device records in Berlin, DE. FDA records list no 510(k) clearances, 52 PMA records and 2 registered establishments. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004582654 | 3004582654 | BERLIN HEART GMBH | Wiesenweg 10, Berlin D-12247 DE | 2026 | |
| 3008454189 | 3008454189 | BERLIN HEART, INC. | 9391 Grogan's Mill Road, The Woodlands, TX 77380 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2320-2026 | EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01 | Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures. | Class II | Open, Classified | |
| Z-1618-2023 | 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. | 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. | Class I | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain