# FDA recall Z-2762-2020

> **Boston Scientific Corporation** · Class II · device recall initiated 2020-07-06.

## Product

Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can  be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension and retraction of the loop from the sheath. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop.

## Reason for recall

BSC has noted a potential inability to cut and  remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.

## Distribution

World wide distribution.

## Key facts

- **Recall number:** Z-2762-2020
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-07-06
- **Report date:** 2020-08-12

- **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-2762-2020

## Citation

> AI Analytics. FDA recall Z-2762-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2762-2020. Source: US FDA. Licensed CC0.

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