# FDA recall Z-1490-2021

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

## Product

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 procedure.    Material No. M0068318210

## 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-1490-2021
- **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-1490-2021

## Citation

> AI Analytics. FDA recall Z-1490-2021. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-1490-2021. Source: US FDA. Licensed CC0.

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