FEI 3004582654
Berlin Heart Gmbh
Wiesenweg 10, Berlin, DE
MDR events869All time
Recalls2All time
Registered products2
Establishment typeManufactureManufacture Medical Device
Registered product codes
2 product codes
Recent MDR events
869 on file
- EXCOR®Jul 27, 2026Injury3004582654-2026-00033
- EXCOR®Jul 27, 2026Injury3008454189-2026-00009
- EXCOR®Jul 27, 2026Malfunction3004582654-2026-00034
- EXCOR®Jul 27, 2026Malfunction3004582654-2026-00035
- EXCOR®Jun 15, 2026Malfunction3004582654-2026-00032
- EXCOR®Jun 2, 2026Malfunction3004582654-2026-00031
- EXCOR®May 18, 2026Injury3004582654-2026-00030
- EXCOR®May 18, 2026Injury3004582654-2026-00029
- EXCOR®May 18, 2026Injury3008454189-2026-00008
- EXCOR®May 11, 2026Injury3004582654-2026-00028
Recalls
2 on file
- Open, ClassifiedJun 5, 2026
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
View FDA record ↗ - TerminatedMay 25, 2023
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.
View FDA record ↗
Compliance history
Matched by FEI 3004582654.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.