# FDA recall Z-1622-2018

> **Boston Scientific Corporation** · Class II · device recall initiated 2018-02-12.

## Product

Uphold LITE w/ Capio SLIM; Model #M0068318170.    Indicated for tissue reinforcement in women with pelvic organ prolapse.

## Reason for recall

Potential for Capio sutures to break and /or detach.

## Distribution

Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark,   Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama,   Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic,   Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia,   Bahrain, Georgia, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia,   Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta,   Namibia, Romania, Switzerland, and Greece.

## Key facts

- **Recall number:** Z-1622-2018
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-12
- **Report date:** 2018-05-16
- **Termination date:** 2020-04-10

- **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-1622-2018

## Citation

> AI Analytics. FDA recall Z-1622-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1622-2018. Source: US FDA. Licensed CC0.

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