Abbott Medical's Complete FDA Record

FDA action counts

Enforcement history

On 2026-06-17, Argus HQ recorded an FDA recall for Abbott Medical, rated "high" severity in Argus HQ's classification: Abbott Medical — Class II recall: Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 33…. 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.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Abbott Medical 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.

Frequently asked questions

How many FDA actions has Abbott Medical had?

Argus HQ has recorded 1 FDA events for Abbott Medical: 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 Abbott Medical?

The most recent FDA event Argus HQ has on file for Abbott Medical 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 Abbott Medical 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 Abbott Medical is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for Abbott Medical?

39 total: 0 warning letters, 39 recalls, 0 approval records, and 0 Form 483 inspection citations.

Related enforcement actions

• Abbott Medical — Class II recall: Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 33… →
• Abbott Medical — Class II recall: Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400 →
• Abbott Medical — Class II recall: Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400 →
• Abbott Medical — Class II recall: Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 0… →
• Abbott Medical — Class II recall: The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 365… →
• Abbott Medical — Class III recall: Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@… →
• Abbott Medical — Class III recall: Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is inte… →
• Abbott Medical — Class II recall: Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 m… →
• Abbott Medical — Class II recall: Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO… →
• Abbott Medical — Class II recall: Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-… →

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