# FDA recall Z-1302-2024

> **Boston Scientific Corporation** · Class I · device recall initiated 2024-02-12.

## Product

Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050

## Reason for recall

Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of POLARSHEATH devices. This could result in the embolization of a fragment during use (such as flushing of the sheath or introduction of the dilator or ablation catheter).

## Distribution

Austria, Belarus, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, and Japan

## Key facts

- **Recall number:** Z-1302-2024
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-12
- **Report date:** 2024-04-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1302-2024

## Citation

> AI Analytics. FDA recall Z-1302-2024. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1302-2024. Source: US FDA. Licensed CC0.

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