Abbott Medical 2024-07-24 Health serious FDA
Health · FDA · Recall #FDA-Z-2359-2024
Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only Recall
Issued July 24, 2024 · Abbott Medical
In July 2024, Abbott Medical recalled the Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Abbott Medical to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Abbott Medical
- Category
- Health
- Recall date
- July 24, 2024
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution including in the states of ALABAMA, ALASKA, ARIZONA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DEL
- Recall number
- FDA-Z-2359-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Abbott Medical has 7 recalls in our database, including 4 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.