Abbott Medical 2024-07-31 Health serious FDA
Health · FDA · Recall #FDA-Z-2432-2024
Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only Recall
Issued July 31, 2024 · Abbott Medical
In July 2024, Abbott Medical recalled the Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
What you should do
- 1 Stop using Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, 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 31, 2024
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC
- Recall number
- FDA-Z-2432-2024
- 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.