PRECISE PRO RX CAROTID STENT implant system — Class I medical device recall Z-1257-2021
Completed recall by Cordis Corporation, reported 2021-03-24, distributed in MT, NM. Distal tip may become separated from the lumen wire in specific lots.
| Recall number | Z-1257-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cordis Corporation, Miami Lakes, FL, United States |
| Recall initiated | 2021-02-11 |
| Classified | 2021-03-15 |
| Reported by FDA | 2021-03-24 |
| Distributed | MT, NM |
| Countries outside the US | TW |
| Quantity | 18,218 units |
| Lot numbers | 17903563, 17904654, 17905295, 17905297, 17906531, 17907242, 17907243, 17907246, 17907250, 17908608, 17909814, 17910548, 17910553, 17910556, 17911879, 17911881, 17912281, 17912285, 17912290, 17913484, 17913485, 17913915, 17914196, 17914198, 17914902, 17915157, 17915158, 17915162, 17916478, 17916479, 17916481, 17916482, 17917082, 17917084, 17917085, 17917086, 17917087, 17917088, 17918070, 17918979 and 145 more |
Product
PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940RXC, PC1030RXC, PC1040RXC
Reason for recall
Distal tip may become separated from the lumen wire in specific lots.
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-1257-2021. 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.