# FDA recall Z-0390-2019

> **Cordis Corporation** · Class II · device recall initiated 2018-09-05.

## Product

Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for postdilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

## Reason for recall

Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).

## Distribution

Worldwide distribution - US Nationwide in the states of AL, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MO, MS, NC, ND, NJ, OH, PA, SC, TN, TX, and WI. Countries of Japan and Netherlands.

## Key facts

- **Recall number:** Z-0390-2019
- **Recalling firm:** Cordis Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-05
- **Report date:** 2018-11-14
- **Termination date:** 2021-02-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Miami Lakes, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0390-2019

## Citation

> AI Analytics. FDA recall Z-0390-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0390-2019. Source: US FDA. Licensed CC0.

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