FDA Medical Device Recalls (openFDA)
Cordis US Corp: PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.
- Recall number
- Z-1363-2022
- Recalling firm
- Cordis US Corp
- Product
- PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.
- Status
- Open, Classified
- Initiated
- 2022-05-20
- Posted
- not on file
- Terminated
- not on file
- Reason
- Potential for stent dislodgement and associated failures related to two specific sizes of the device.
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K033394"]
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 1016427
- Firm city
- Miami Lakes
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28