# FDA recall Z-1169-2021

> **Boston Scientific Corporation** · Class II · device recall initiated 2021-01-19.

## Product

Captivator II Single-Use Polypectomy Snares     Outer box UPN, Inner Pouch UPN:    M00561191 (Box 10), M00561190;    M00561221 (Box 10), M00561220;    M00561222 (Box 20), M00561220;    M00561223 (Box 40), M00561220;    M00561233 (Box 40), M00561230.

## Reason for recall

Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.

## Distribution

US nationwide distribution.

## Key facts

- **Recall number:** Z-1169-2021
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-01-19
- **Report date:** 2021-03-10

- **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-1169-2021

## Citation

> AI Analytics. FDA recall Z-1169-2021. Retrieved 2026-09-27 from https://api.ai-analytics.org/recall/Z-1169-2021. Source: US FDA. Licensed CC0.

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