Z-1363-2022 Class II Ongoing
FDA device recall Z-1363-2022 was initiated by Cordis US Corp on May 20, 2022 and is designated Class II. Reason for recall: Potential for stent dislodgement and associated failures related to two specific sizes of the device. The recall status is ongoing. Affected quantity: 1,089 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 20, 2022
- Initiation Date
- May 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,089 units
Product Description
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 Pattern
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.
Code Information
Catalog #PG2990BPS - Lot numbers 82184806, exp. 12/31/2022; 82191321, exp. 3/31/2023; and 82208532, exp. 10/31/2023. Catalog #PG2990BPX - Lot numbers 82185924, exp. 1/31/2023; and 82208528, exp. 10/31/2023. Catalog #PG3990BPS - Lot numbers 82180267, exp. 10/31/2022; 82191527, exp. 3/31/2023; 82193089, exp. 5/31/2023; and 82206059, exp. 10/31/2023. Catalog #PG3990BPX - Lot numbers 82208524, exp. 11/30/2023; and 82211296, exp. 12/31/2023.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1363-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026