Boston Scientific recalls SpaceOAR Vue System (UPN SV-1010/SV-2101) due to potential embolism from hydrogel misplacement during prostate cancer radiotherapy. Updated instructions help verify correct placement.
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.
Boston Scientific is recalling SpaceOAR Vue System devices (UPN SV-1010 and SV-2101) used in prostate cancer radiotherapy. The recall is due to a risk of embolism if the hydrogel material is misplaced during implantation, though updated instructions help verify correct placement.
Hydrogel material in the SpaceOAR system can become misplaced during implantation, potentially causing embolism (blockage of blood vessels). The updated instructions help verify correct placement to reduce this risk.
Patients receiving prostate cancer radiotherapy who use these devices are most at risk. Healthcare providers who implant the devices may also be affected.
Check for the SpaceOAR Vue System with model numbers UPN SV-1010 or SV-2101. Batch numbers listed in the recall record include specific numbers starting with 26345481 through 28838125.
Follow updated instructions to check if the hydrogel is correctly positioned after implantation.
The device is safe when used correctly, but the recall addresses a potential risk of embolism from hydrogel misplacement. Updated instructions help verify correct placement.
If you have the recalled devices, follow the updated instructions to verify correct placement. Contact Boston Scientific for further guidance.
Check the model number (UPN SV-1010 or SV-2101) and batch numbers listed in the recall record, which range from 26345481 to 28838125.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1003-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1003-2022 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
