Has Abbott Medical had other FDA enforcement actions?

Yes. Argus HQ has recorded 39 total FDA actions tied to Abbott Medical: 0 warning letters, 39 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 high severity by Argus HQ. FDA published the underlying record on 2023-09-27; 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.

.hq

fda_recall · device_recall · high

Abbott Medical — Class II recall: Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA5…

Name: FDA Recall Record — Abbott Medical
Creator: Argus HQ
Published: 2023-09-27
License: https://argushq.ai/methodology

Event date: 2023-09-27 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-2615-2023
Payload hash: c246538e558c0487f9611234…

Summary

Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchronization Therapy Defibrillator *CRT-D) devices that were manufactured prior to April 2022 as a result of crystal component issue within the Bluetooth Low Energy (BLE) circuit. This results in… Status: Ongoing.

Entities

Abbott Medical

View source record ↗

Frequently asked questions

Has Abbott Medical had other FDA enforcement actions?: Yes. Argus HQ has recorded 39 total FDA actions tied to Abbott Medical: 0 warning letters, 39 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 high severity by Argus HQ. FDA published the underlying record on 2023-09-27; 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). Abbott Medical — Class II recall: Gallant HF Cardiac Resynchronization Therapy Defibrillator:  HF CRT-D REF CDHFA5…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-abbott-medical-z-2615-2023

MLA

"Abbott Medical — Class II recall: Gallant HF Cardiac Resynchronization Therapy Defibrillator:  HF CRT-D REF CDHFA5…." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/events/fda-recall-abbott-medical-z-2615-2023.

Chicago

Argus HQ Research. "Abbott Medical — Class II recall: Gallant HF Cardiac Resynchronization Therapy Defibrillator:  HF CRT-D REF CDHFA5…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-abbott-medical-z-2615-2023.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_abbott_medical_z_2615_2023_2023,
  title = {Abbott Medical — Class II recall: Gallant HF Cardiac Resynchronization Therapy Defibrillator:  HF CRT-D REF CDHFA5…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-abbott-medical-z-2615-2023},
  note = {Accessed: July 23, 2026}
}

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