Boston Scientific Corporation 2022-05-04 Health serious FDA
Health · FDA · Recall #FDA-Z-1002-2022
SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily… Recall
Issued May 4, 2022 · Boston Scientific Corporation
In May 2022, Boston Scientific Corporation recalled the SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily…, a serious 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
Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following implantation, as well as technique recommendations for the proper placement of SpaceOAR and SpaceOAR Vue.
What you should do
- 1 Stop using SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Boston Scientific Corporation 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
- Boston Scientific Corporation
- Category
- Health
- Recall date
- May 4, 2022
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution.
- Recall number
- FDA-Z-1002-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Boston Scientific Corporation has 35 recalls in our database, including 13 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.