SpaceOAR System — Class II medical device recall Z-1002-2022
Ongoing recall by Boston Scientific Corporation, reported 2022-05-04, distributed nationwide. Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updat
| Recall number | Z-1002-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2022-02-24 |
| Classified | 2022-04-25 |
| Reported by FDA | 2022-05-04 |
| Distributed | Nationwide (US) |
| Quantity | 61,852 units |
| UPC / GTIN / UDI-DI | 00864661000102, 00864661000126, 00864661000157, 00864661000164 |
| Lot numbers | 25447885, 25449321, 25449325, 25450979, 25454386, 25454387, 25454390, 25461459, 25495940, 25498279, 25498740, 25498741, 25498742, 25503112, 25503113, 25503114, 25503115, 25503116, 25506791, 25512955, 25512956, 25513909, 25513910, 25513911, 25513912, 25516002, 25516004, 25518766, 25518767, 25518769, 25518770, 25604214, 25604215, 25608548, 25608549, 25630371, 25630372, 25630373, 25633109, 25638880 and 460 more |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1002-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.