Z-1363-2022Class II

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

Name: Z-1363-2022 PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS...
Creator: Cordis US Corp
Published: 2022-05-20
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2022-05-20 / Open, Classified / root cause: manufacturing process

FDA source

Cordis US Corp began a recall of PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX on 2022-05-20. FDA classified it as Class II and gives the reason as "Potential for stent dislodgement and associated failures related to two specific sizes of the device". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1363-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-20
Posted: 2022-07-11
Recalling firm: Cordis US Corp.
Product: PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: Potential for stent dislodgement and associated failures related to two specific sizes of the device.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The recalling firm issued letters dated 5/16/2022 on 5/20/2022 via FedEx to the U.S. customers. The letter explained the issue, provided details on the affected device to assist in the identification of the product involved, and requested the consignee immediately check their inventory for the affected product and quarantine it. An Acknowledgment Form was enclosed for completion and return to the recalling firm. The consignee was to share the letter with others in their facility who need to be made aware of the recall and with any other facility that may have been sent the affected units.
Quantity in commerce: 1,089 units
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1363-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1363-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-20	2022-07-11

Product code FGE

K033394Class IICordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035 Delivery SystemCordis Corp. / cleared 2003-12-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)