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fda_recall · device_recall · high

Abbott Medical — Class II recall: Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx Onl…

Event date
2024-07-24 00:00:00Z
Observed
2026-07-16 23:20:09Z
Source ID
Z-2366-2024
Payload hash
19f3969d1bd258ce657954d7

Summary

The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling. Status: Ongoing.

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 2024-07-24; 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 (2024). Abbott Medical — Class II recall: Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx Onl…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-abbott-medical-z-2366-2024
MLA
"Abbott Medical — Class II recall: Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx Onl…." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/events/fda-recall-abbott-medical-z-2366-2024.
Chicago
Argus HQ Research. "Abbott Medical — Class II recall: Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx Onl…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-abbott-medical-z-2366-2024.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_abbott_medical_z_2366_2024_2024,
  title = {Abbott Medical — Class II recall: Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx Onl…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-abbott-medical-z-2366-2024},
  note = {Accessed: July 23, 2026}
}

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