# FDA recall Z-1491-2021

> **Boston Scientific Corporation** · Class II · device recall initiated 2021-04-15.

## 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

## 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.

## Key facts

- **Recall number:** Z-1491-2021
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-04-15
- **Report date:** 2021-05-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marlborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1491-2021

## Citation

> AI Analytics. FDA recall Z-1491-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1491-2021. Source: US FDA. Licensed CC0.

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