# FDA recall Z-1198-2019

> **Cordis Corporation** · Class III · device recall initiated 2019-02-07.

## Product

Cordis Vista Brite Tip & Androit Guiding Catheters    Product Usage:  The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.

## Reason for recall

Frayed pieces of the mounting card being inside the primary packaging.

## Distribution

Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and Guam  Singapore and Canada

## Key facts

- **Recall number:** Z-1198-2019
- **Recalling firm:** Cordis Corporation
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-07
- **Report date:** 2019-04-24
- **Termination date:** 2021-11-03

- **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-1198-2019

## Citation

> AI Analytics. FDA recall Z-1198-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1198-2019. Source: US FDA. Licensed CC0.

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