# FDA recall Z-1940-2020

> **Cook Inc.** · Class II · device recall initiated 2020-04-15.

## Product

Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611    Balloon-expandable stent made of 316L stainless steel with a slotted tube configuration. It is pre-mounted on an over-the-wire balloon catheter, which serves as the delivery system. The stent is positioned between two radiopaque marker bands, which are located inside the balloon at the proximal and distal tapers of the balloon.

## Reason for recall

The firm received complaints on five devices from one specific lot where the stent dislodged from the balloon delivery system prior to deployment. Use of affected product may lead to increased procedural time and additional intervention to remove a stent that dislodged within an unintended location.

## Distribution

Domestic distribution to OH, IA, VA, and NC. Foreign distribution to Canada.

## Key facts

- **Recall number:** Z-1940-2020
- **Recalling firm:** Cook Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-15
- **Report date:** 2020-05-20
- **Termination date:** 2024-04-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1940-2020

## Citation

> AI Analytics. FDA recall Z-1940-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1940-2020. Source: US FDA. Licensed CC0.

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