BERLIN HEART GMBH
BERLIN HEART GMBH appears in FDA public data with 2 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2320-2026, Class II) was initiated on April 24, 2026.
Summary
- Total Recalls
- 2 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2320-2026 | Class II | EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 3 | April 24, 2026 |
| Z-1618-2023 | Class I | EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-0 | May 18, 2018 |