Cordis PRECISE — Class II medical device recall Z-1946-2016
Terminated recall by Cordis Corporation, reported 2016-06-22, distributed nationwide. Inability to deploy the stent or partial stent deployment.
| Recall number | Z-1946-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cordis Corporation, Miami Lakes, FL, United States |
| Recall initiated | 2016-05-04 |
| Classified | 2016-06-10 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2019-07-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP, KR, TH, TW |
| Lot numbers | 17247325, 17249849, 17249850, 17250948, 17250952, 17251834, 17251837, 17251838, 17253599, 17253601, 17255095, 17256203, 17256214, 17256217, 17259051, 17259977, 17259979, 17260987, 17260988, 17260989, 17264566, 17264568, 17264569, 17264571, 17264572, 17264995, 17264998, 17265886, 17268217, 17268219, 17269319, 17270630, 17270632, 17272818, 17274483, 17274485, 17276754, 17276782, 17280875, 17280877 and 133 more |
| Model numbers | PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940RXC, PC1020RXC, PC1030RXC, PC1040RXC |
Product
Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)
Reason for recall
Inability to deploy the stent or partial stent deployment.
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-1946-2016. 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.