FDA action counts
| Total FDA actions | 120 |
|---|---|
| Warning letters | 0 |
| Recalls | 120 |
| Approval records | 0 |
| Form 483 inspection citations | 0 |
| Most recent action | June 28, 2023 |
Risk pattern analysis
Argus HQ analysis — not an FDA finding
This section is Argus HQ analysis, not an FDA finding. Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 120 separate FDA recalls on file, more than a single isolated recall event. 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.
Enforcement history
On 2023-06-28, Argus HQ recorded an FDA recall for Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), rated "critical" severity in Argus HQ's classification: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; Implantable Cardioverter…. On 2023-06-28, Argus HQ recorded an FDA recall for Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), rated "critical" severity in Argus HQ's classification: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; Implantable Cardiove…. On 2023-06-28, Argus HQ recorded an FDA recall for Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), rated "critical" severity in Argus HQ's classification: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ; Implantable Cardiov…. On 2023-06-28, Argus HQ recorded an FDA recall for Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), rated "critical" severity in Argus HQ's classification: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: ICD-VR DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4; Implantable Cardiover…. On 2023-06-28, Argus HQ recorded an FDA recall for Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), rated "critical" severity in Argus HQ's classification: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; Implantable Cardioverte…. On 2023-06-28, Argus HQ recorded an FDA recall for Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), rated "critical" severity in Argus HQ's classification: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: ICD COBALT VR MRI IS1 DF1, Model Number DVPB3D1; Implantable Cardioverter Defib…. On 2023-06-28, Argus HQ recorded an FDA recall for Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), rated "critical" severity in Argus HQ's classification: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: ICD COBALT XT VR MRI IS1 DF1, Model Number DVPA2D1; Implantable Cardioverter De…. On 2023-06-28, Argus HQ recorded an FDA recall for Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), rated "critical" severity in Argus HQ's classification: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; Implantable Cardiov…. On 2023-06-28, Argus HQ recorded an FDA recall for Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), rated "critical" severity in Argus HQ's classification: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardio…. On 2023-06-28, Argus HQ recorded an FDA recall for Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), rated "critical" severity in Argus HQ's classification: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1; Implantable Cardiove…. On 2023-06-28, Argus HQ recorded an FDA recall for Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), rated "critical" severity in Argus HQ's classification: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: ICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; Implantable Cardiove…. On 2023-06-28, Argus HQ recorded an FDA recall for Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), rated "critical" severity in Argus HQ's classification: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: CRTD DTMB2QQ AMPLIA MRI QUAD OUS DF4, Model Number DTMB2QQ; Implantable Cardiov….
Frequently asked questions
- Does Argus HQ track new FDA actions for Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) 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 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is observed, this page's event count and history update automatically.
- How many FDA actions does Argus HQ track for Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)?
- 120 total: 0 warning letters, 120 recalls, 0 approval records, and 0 Form 483 inspection citations.
- What is the most recent FDA action on file for Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)?
- June 28, 2023. Argus HQ ingests new FDA enforcement records daily.
- Has Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) had product recalls?
- Yes, 120 recalls on file. See the full history below for each one.
Every FDA action tied to this company, the week it happens.
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Related enforcement actions
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: ICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1; Implantable Cardioverter Defibr… →
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; Implantable Cardioverter… →
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; Implantable Cardioverter… →
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: ICD COBALT XT HF QUAD OUS, Model Number DTPA2QQG; Implantable Cardioverter Defi… →
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; Implantable Cardiover… →
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; Implantable Cardiover… →
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: ICD-VR DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1; Implantable Cardiover… →
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: ICD CROME DR MRI IS1 DF4, Model Number DDPC3D4; Implantable Cardioverter Defibr… →
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: ICD COBALT DR MRI IS1 DF4, Model Number DDPB3D4; Implantable Cardioverter Defib… →
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: ICD-VR DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4; Implantable Cardioverter D… →
Compare with
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) vs Philips North America
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) vs Boston Scientific Corporation
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) vs Medline Industries, LP
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) vs Baxter Healthcare Corporation
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) vs PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Two different companies merged onto this page by mistake? Or a name variant missing? Tell us — corrections@argushq.ai
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Verified from FDA.gov · Last updated: Jun 28, 2023Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2023). FDA Actions Against Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Digital Empire LLC. Retrieved from https://argushq.ai/company/medtronic-inc-cardiac-rhythm-and-heart-failure-crhf
"FDA Actions Against Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)." Argus HQ Research, Digital Empire LLC, 2023, argushq.ai/company/medtronic-inc-cardiac-rhythm-and-heart-failure-crhf.
Argus HQ Research. "FDA Actions Against Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/company/medtronic-inc-cardiac-rhythm-and-heart-failure-crhf.
@misc{argushq_argushq_ai_company_medtronic_inc_cardiac_rhythm_and_heart_failure_crhf_2023,
title = {FDA Actions Against Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)},
author = {{Argus HQ Research}},
year = {2023},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/company/medtronic-inc-cardiac-rhythm-and-heart-failure-crhf},
note = {Accessed: July 17, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗