Skip to main content

fda_recall · device_recall · critical

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ; Implantable Cardioverter…

Event date
2023-06-28 00:00:00Z
Observed
2026-07-16 23:20:09Z
Source ID
Z-1788-2023
Payload hash
8977072c0bd3ccab2ca5fb49…

Summary

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently availa… Status: Ongoing.

Entities

View source record ↗

Frequently asked questions

Has Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) had other FDA enforcement actions?
Yes. Argus HQ has recorded 120 total FDA actions tied to Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): 0 warning letters, 120 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Recall, tagged critical severity by Argus HQ. FDA published the underlying record on 2023-06-28; Argus observed and indexed it on 2026-07-16.
Where can I verify this record directly with FDA?
The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

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

Cite this record

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

APA
Argus HQ Research (2023). Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ;  Implantable Cardioverter…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-medtronic-inc-cardiac-rhythm-and-heart-failure-crhf-z-1788-2023
MLA
"Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ;  Implantable Cardioverter…." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/events/fda-recall-medtronic-inc-cardiac-rhythm-and-heart-failure-crhf-z-1788-2023.
Chicago
Argus HQ Research. "Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ;  Implantable Cardioverter…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-medtronic-inc-cardiac-rhythm-and-heart-failure-crhf-z-1788-2023.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_medtronic_inc_cardiac_rhythm_and_heart_failure_crhf_z_1788_2023_2023,
  title = {Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ;  Implantable Cardioverter…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-medtronic-inc-cardiac-rhythm-and-heart-failure-crhf-z-1788-2023},
  note = {Accessed: July 23, 2026}
}

Informational only. Not legal, financial, or medical advice.

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Class I recall: CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ; Implantable Cardioverter… · Argus HQ