Data / Medical devices / Germany / Berlin Heart GMBH
Berlin Heart GMBH: FDA-registered device maker in Berlin, Germany, 1 PMA approval
Berlin Heart GMBH is registered with the FDA (registration 3004582654) in Berlin, Germany. It lists 2 device types. The FDA files 1 PMA approval under its listings, the newest dated June 6, 2017. 2 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004582654
- Address
- Wiesenweg 10 Steglitz, Berlin, Germany, D-12247
- Owner or operator
- Berlin Heart GmbH (10039961)
- Roles
- Manufacturer
- First device listed
- March 2, 2012
- Registered through
- 2026
- Brand names listed
- EXCOR Pediatric Ventricular Assist Device, EXCOR® Pediatric Ventricular Assist Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pediatric Ventricular Assist Device | PCK | f | Manufacturer | accessdata.fda.gov |
| Ventricular (Assist) Bypass | DSQ | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| June 6, 2017 | P160035 | EXCOR Pediatric Ventricular Assist Device | DSQ | 55 | October 23, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 24, 2026 | 98797 | Class II | Ongoing | 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. | accessdata.fda.gov |
| May 18, 2018 | 92132 | Class I | Terminated | 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-0 | 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. | accessdata.fda.gov |
Compare with other makers
Updated October 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.