# FDA recall Z-3147-2024

> **Boston Scientific Corporation** · Class II · device recall initiated 2024-07-18.

## Product

Flexima APDL Drainage Catheter System and Kit, Material Numbers:  a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail

## Reason for recall

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

## Distribution

US, Colombia, Philippines, Russia

## Key facts

- **Recall number:** Z-3147-2024
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-07-18
- **Report date:** 2024-09-25

- **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-3147-2024

## Citation

> AI Analytics. FDA recall Z-3147-2024. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-3147-2024. Source: US FDA. Licensed CC0.

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