Cordis Precise Nitinol Stent System — Class II medical device recall Z-0729-2020
Ongoing recall by Cardinal Health Inc., reported 2020-01-01, distributed nationwide. Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information
| Recall number | Z-0729-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health Inc., Dublin, OH, United States |
| Recall initiated | 2019-11-14 |
| Classified | 2019-12-20 |
| Reported by FDA | 2020-01-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GT, HK, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, KW, LB, LT, LU, LV, MA, MT, MX, MY, NL, NO, NZ, OM, PA, PE, PH, PL, PT, QA, SE, SK, TH, TR, UA, UY, VE, ZA |
| Reason classes | labeling |
Product
Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent System devices are designed to deliver a flexible, self-expanding endoluminal stent to the carotid vasculature via over-the-wire (OTW) 5.5F or 6F sheathed delivery systems. The stent is cut from a solid nitinol tube into a fine mesh ( Z configuration) design. The delivery systems consist mainly of an inner shaft and an outer sheath with radiopaque markers, and a Tuohy Borst valve. The inner shaft terminates distally in a catheter tip and originates proximally in a luer hub designed to accept a 0.018 guidewire. The delivery systems have a nominal working length of 135 cm. The self-expanding PRECISE stent is constrained within the space between the inner shaft and the outer sheath, located between distal and proximal stent makers on the inner shaft. The stent expands to its unconstrained diameter when released from the deployment catheter into the carotid artery. Upon deployment the stent forms an open lattice and pushes outward on the luminal surface, helping to maintain the patency of the artery. Due to the self-expanding behavior of nitinol, the stents are indicated for placement into vessels that are 1-2mm smaller in diameter than the unconstrained diameter of the stent.
Reason for recall
Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".
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-0729-2020. 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.