# FDA recall Z-1663-2024

> **Boston Scientific Corporation** · Class I · device recall initiated 2024-03-21.

## Product

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF H749085262522; cardiac catheter

## Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

## Distribution

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM  and Asia Pacific countries/regions.

## Key facts

- **Recall number:** Z-1663-2024
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-21
- **Report date:** 2024-05-22

- **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-1663-2024

## Citation

> AI Analytics. FDA recall Z-1663-2024. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-1663-2024. Source: US FDA. Licensed CC0.

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