Abbott Medical 2023-09-20 Health critical FDA
Health · FDA · Recall #FDA-Z-2505-2023
Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5… Recall
Issued September 20, 2023 · Abbott Medical
In September 2023, Abbott Medical recalled the Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
What you should do
- 1 Stop using Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5… 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
- September 20, 2023
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA
- Recall number
- FDA-Z-2505-2023
- 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 903rd Health recall we've logged in 2023.