How many FDA warning letters has BERLIN HEART GMBH received?

Argus HQ has not recorded an FDA warning letter for BERLIN HEART GMBH in our current dataset.

What FDA recalls has BERLIN HEART GMBH issued?

Argus HQ has recorded 1 FDA recall tied to BERLIN HEART GMBH.

Is BERLIN HEART GMBH FDA compliant?

Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 1 recall, and 0 approval records for BERLIN HEART GMBH. Review the linked FDA source records directly before drawing a compliance conclusion.

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company

BERLIN HEART GMBH

Name: FDA Enforcement Actions Against BERLIN HEART GMBH
Creator: Argus HQ
License: https://argushq.ai/methodology

Jurisdiction: US

FDA Warning Letter timeline

V1 scope: FDA Warning Letters only. Additional public-record sources (SEC, CPSC, federal contracts) are on the V2 roadmap and are not surfaced here today.

fda_recall · device_recall2026-06-17
BERLIN HEART GMBH — Class II recall: EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10…

Frequently asked questions

How many FDA warning letters has BERLIN HEART GMBH received?: Argus HQ has not recorded an FDA warning letter for BERLIN HEART GMBH in our current dataset.
What FDA recalls has BERLIN HEART GMBH issued?: Argus HQ has recorded 1 FDA recall tied to BERLIN HEART GMBH.
Is BERLIN HEART GMBH FDA compliant?: Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 1 recall, and 0 approval records for BERLIN HEART GMBH. Review the linked FDA source records directly before drawing a compliance conclusion.

Informational only. FDA Warning Letters are public records (17 USC §105). Summaries are AI-assisted and may contain errors; always verify against the original FDA letter before acting. Not legal, financial, or regulatory advice.