Reported May 4, 2022 · Ongoing
SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away…
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 System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. 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 SO-1010GTIN 00864661000157
- Batch Numbers
109 of 109 codes
255129552551295625608548256461052565224625676663256766642568178325814685258146862581468725822800258228122582281425822815258228182584648126059500261991522619915326199154261991552622396126223962262239632622396426223965262496632629656726296568263306922633069326330694263306952636053526360536263926792645067326450674264506752647909326514195265141962651419726514198265521422655214326552144265521452655214626552147265521482655214926552150265596752658224526582246265822472658224826604083
- Batch Numbers
819 of 819 codes
254478852544932525454386254543872546145925495940254982792549874025498741254987422550311225503113255031142550311525503116255067912551390925513910255139112551391225516002255160042551876625518767255187692551877025604214256042152560854925630371256303722563037325633109256388802563888125638882256388832564031625640317256461062565037525650376256522482565224925652250256602512566025225661506256652612566526225665263256817842568649025686491256920432569895925699200256992012569920225706244
- Batch Numbers
2598543926140617261406182614061926141060261410612614106226170538262496622651760528377015UPN SO-4101GTIN 00864661000126
- Batch Numbers
159 of 159 codes
254493212545097925454390257314152573141625731579257322202576563225765633257656342581468225814683258380152583801625838017258380182585288425980707259807082598070925980710259807112602105026021051260210522602105326060390260603912607145626071458261115082611150926111510261115112617053926199156262489012624890226257959262584002628776826287769262945662629456726334369263343702636053326360534264366892643669026436691264366922643669326436694264366952643669626479094265596762655967726559678
- Amount recalled
- 61,852 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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