# FDA recall Z-1582-2022

> **Boston Scientific Corporation** · Class II · device recall initiated 2022-08-09.

## Product

Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440

## Reason for recall

The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.

## Distribution

International distribution in the countries of Greece, France, Germany, Italy, Brazil and South Korea.  UPDATE:  The devices were also distributed to Russia.  There was no U.S. distribution.

## Key facts

- **Recall number:** Z-1582-2022
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-08-09
- **Report date:** 2022-08-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maple Grove, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1582-2022

## Citation

> AI Analytics. FDA recall Z-1582-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1582-2022. Source: US FDA. Licensed CC0.

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