Cordis US Corp PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.
Brand
Cordis US Corp
Lot Codes / Batch Numbers
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.
Products Sold
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.
Cordis US Corp is recalling PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990B due to Potential for stent dislodgement and associated failures related to two specific sizes of the device.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for stent dislodgement and associated failures related to two specific sizes of the device.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026