UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning… recallZ-1491-2021 · Boston Scientific Corporation · initiated Apr 15, 2021

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
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Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Packaging process control

What the company is doing

Boston Scientific issued Urgent Medical Device Product Removal on 4/15/21 via FedX. Letter states reason for recall, health risk and action to take; Individually packaged Upsylon Y Mesh (UPN M0068318200) is not impacted by this removal. This removal affects only the UPNs and batches listed below and in Attachment 1. No other UPNs or batches are impacted by this removal. Please cease further distribution or use of any remaining product affected by this removal immediately. If you identify any product from the affected lots/batches within your inventory, please segregate the product immediately and return it to BSC in accordance with the enclosed instructions and indicate on your Reply Verification Tracking Form the quantity of units from each lot/batch that you will be returning. BSC is notifying regulatory authorities of this removal as required. Please read carefully through the removal instructions included with this notification. Your local Sales Representative can answer any questions that you may have regarding this notification.

Recall details

Recall number: Z-1491-2021
Status: Open, Classified
Initiated by the company: Apr 15, 2021
Recalling firm: Boston Scientific Corporation
Quantity: 8,524 WW
Product code: OHD
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Algeria, Brazil, Colombia, Estonia, Germany, Hong Kong, Australia, Canada, Costa Rica, Finland, Great Britain, Italy, Austria, Chile, Czech Republic, France, Greece, Jordan, Belgium, Lebanon, Mauritius, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan.

Product description

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.

Code information (models, lots, serial numbers)

All unexpired lots: 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 C004143 C004150 C004159 C004175 C004176 C004196 C004205 C004213 C004218 C004223 GTIN: 08714729848103

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Upsylon™ Y Mesh Kit M0068318220
Boston Scientific Corporation · Gynecological laparoscopic kit
1 recall44 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 87709).

Z-1490-2021 · Open, Classified
Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the proc…

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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