UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device — Class II medical device recall Z-1491-2021
Ongoing recall by Boston Scientific Corporation, reported 2021-05-05, distributed nationwide. Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-
| Recall number | Z-1491-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2021-04-15 |
| Classified | 2021-04-23 |
| Reported by FDA | 2021-05-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CL, CO, CR, CZ, DE, DZ, EE, ES, FI, FR, GB, GR, HK, IT, JO, LB, MA, MX, NL, NO, NZ, PA, PL, PT, RS, SE, SI, SK, TW, ZA |
| Quantity | 8,524 ww |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 08714729848103 |
| Lot numbers | C003726, C003737, C003739, C003752, C003767, C003778, C003782, C003791, C003814, C003818, C003831, C003845, C003846, C003874, C003875, C003898, C003899, C003921, C003942, C003954, C003970, C003988, C003989, C003999, C004000, C004011, C004012, C004031, C004032, C004033, C004048, C004049, C004084, C004085, C004086, C004097, C004098, C004099, C004120, C004132 and 10 more |
Product
UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic or robotic approach Material No.M0068318220 Individually packaged Upsylon Y Mesh (UPN M0068318200) is not impacted by this removal. Note: The UpsylonTM Y Mesh Kit consists of UpsylonTM Y Mesh and ColpassistTM Vaginal Positioning Device packaged and sterilized separately and then combined into a kit carton. This removal does not affect the UpsylonTM Y Mesh component of the kit, however, since the Colpassist device component is impacted, the entire UpsylonTM Y Mesh kit is being removed.
Reason for recall
Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection
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-1491-2021. 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.