Boston Scientific recalls SpaceOAR System models SO-1010, SO-2101, SO-3101, and SO-4101 due to possible 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 specific versions of their SpaceOAR System for temporary prostate cancer treatment. The recall is because there's a risk of embolism (blood clots) if the hydrogel material isn't placed correctly during surgery. The company has updated instructions to help doctors check proper placement.
The hydrogel material in the SpaceOAR System can move incorrectly during surgery, potentially causing blood clots (embolism) in the body. Updated instructions help doctors verify proper placement to reduce this risk.
Patients receiving prostate cancer radiotherapy using the recalled SpaceOAR System models are most at risk. Healthcare providers who use these products for treatment should check if they have the affected models.
Check for the model numbers SO-1010, SO-2101, SO-3101, or SO-4101 with the listed batch numbers and GTIN codes. These products were used to temporarily position the rectal wall away from the prostate during radiotherapy.
Identify if your SpaceOAR System has model numbers SO-1010, SO-2101, SO-3101, or SO-4101 with the listed batch numbers.
If you have the recalled model, follow the updated instructions to check hydrogel placement before and after treatment.
The SpaceOAR System is generally safe but has a risk of embolism if not placed correctly. Boston Scientific has updated instructions to help verify proper placement.
Check your product model and batch numbers against the list provided. If you have the recalled model, follow the updated instructions to verify hydrogel placement.
Look for model numbers SO-1010, SO-2101, SO-3101, or SO-4101 with the specific batch numbers listed in the recall notice.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1002-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1002-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
