# FDA recall Z-1363-2022

> **Cordis US Corp** · Class II · device recall initiated 2022-05-20.

## Product

PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.

## Reason for recall

Potential for stent dislodgement and associated failures related to two specific sizes of the device.

## Distribution

US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI,  and WY.  There was also government/military distribution.

## Key facts

- **Recall number:** Z-1363-2022
- **Recalling firm:** Cordis US Corp
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-05-20
- **Report date:** 2022-07-20

- **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-1363-2022

## Citation

> AI Analytics. FDA recall Z-1363-2022. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1363-2022. Source: US FDA. Licensed CC0.

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