PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO — Class II medical device recall Z-1363-2022
Ongoing recall by Cordis US Corp, reported 2022-07-20, distributed nationwide. Potential for stent dislodgement and associated failures related to two specific sizes of the device.
| Recall number | Z-1363-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cordis US Corp, Miami Lakes, FL, United States |
| Recall initiated | 2022-05-20 |
| Classified | 2022-07-11 |
| Reported by FDA | 2022-07-20 |
| Distributed | Nationwide (US) |
| Quantity | 1,089 units |
| Lot numbers | 82180267, 82184806, 82185924, 82191321, 82191527, 82193089, 82206059, 82208524, 82208528, 82208532, 82211296 |
| Model numbers | PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX |
| Expiration dates | 2022-10-31, 2022-12-31, 2023-01-31, 2023-03-31, 2023-05-31, 2023-10-31, 2023-11-30, 2023-12-31 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1363-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.