# FDA recall Z-0463-2024

> **Wilson-Cook Medical Inc.** · Class II · device recall initiated 2023-11-03.

## Product

QUANTUM TTC BILIARY BALLOON DILATOR, REF  QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree

## Reason for recall

Nonconforming devices while manufactured correctly, do not comply to their design requirements.  Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.

## Distribution

US

## Key facts

- **Recall number:** Z-0463-2024
- **Recalling firm:** Wilson-Cook Medical Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-03
- **Report date:** 2023-12-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Winston Salem, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0463-2024

## Citation

> AI Analytics. FDA recall Z-0463-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0463-2024. Source: US FDA. Licensed CC0.

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