Reported May 4, 2022 · Ongoing
SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior rectal wall away from the…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum.
- Lot codes and dates
UPN SV-1010GTIN 00850009803009
- Batch Numbers
263832092638321026517604268615842686158526891612268916132708378427190242272105602725780127257802274559662745596727496959274971402767095627708041277080422770804327930863279308642794112927941130279493152809407728247077282470782835877828377018283770192846479428464795284964612849646228578758285787592860823128608232UPN SV-2101GTIN 00864661000140
- Batch Numbers
356 of 356 codes
263454812637696126376962263769632637696426380456263804572638405526384056264088492648597426485975264859772648658626486587264865882649346126517606265176072652971926567283265672842656728526567286265672872657437326574374265743782657437926574441266115932661159426611595266522862665228726691824266918262669182726691828267055632670556426705565267055662672856426728565267437692674377026743771267437722674505726770161267701622677016326770164267701652686158626880769268807702688077126880772
- Amount recalled
- 23,368 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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