Is this FDA enforcement data for BERLIN HEART GMBH official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

How many FDA actions has BERLIN HEART GMBH had?

Argus HQ has recorded 1 FDA events for BERLIN HEART GMBH: 0 warning letters, 1 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

What is the most recent FDA action against BERLIN HEART GMBH?

The most recent FDA event Argus HQ has on file for BERLIN HEART GMBH is dated 2026-06-17, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Does Argus HQ track new FDA actions for BERLIN HEART GMBH automatically?

Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to BERLIN HEART GMBH is observed, this page's event count and history update automatically.

BERLIN HEART GMBH — FDA Enforcement History

FDA action counts

Total FDA actions	1
Warning letters	0
Recalls	1
Approval records	0
Form 483 inspection citations	0
Most recent action	June 17, 2026

Key takeaway: Argus HQ has recorded 1 FDA events for BERLIN HEART GMBH: 0 warning letters, 1 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2026-06-17 to 2026-06-17. The most severe rating Argus HQ has assigned across this history is "high". Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. BERLIN HEART GMBH has 1 FDA event on file. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Enforcement history

On 2026-06-17, Argus HQ recorded an FDA recall for BERLIN HEART GMBH, rated "high" severity in Argus HQ's classification: BERLIN HEART GMBH — Class II recall: EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10…. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Frequently asked questions

Is this FDA enforcement data for BERLIN HEART GMBH official?: Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.
How many FDA actions has BERLIN HEART GMBH had?: Argus HQ has recorded 1 FDA events for BERLIN HEART GMBH: 0 warning letters, 1 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
What is the most recent FDA action against BERLIN HEART GMBH?: The most recent FDA event Argus HQ has on file for BERLIN HEART GMBH is dated 2026-06-17, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
Does Argus HQ track new FDA actions for BERLIN HEART GMBH automatically?: Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to BERLIN HEART GMBH is observed, this page's event count and history update automatically.

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BERLIN HEART GMBH — Class II recall: EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10… →

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Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Verified from FDA.gov · Last updated: Jun 17, 2026

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). BERLIN HEART GMBH — FDA Enforcement History. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/company/berlin-heart-gmbh

MLA

"BERLIN HEART GMBH — FDA Enforcement History." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/company/berlin-heart-gmbh.

Chicago

Argus HQ Research. "BERLIN HEART GMBH — FDA Enforcement History." Digital Empire Holdings LLC. Accessed August 29, 2026. https://argushq.ai/company/berlin-heart-gmbh.

BibTeX

@misc{argushq_argushq_ai_company_berlin_heart_gmbh_2026,
  title = {BERLIN HEART GMBH — FDA Enforcement History},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/company/berlin-heart-gmbh},
  note = {Accessed: August 29, 2026}
}

Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗