FDA Device recall Z-0729-2020
Cordis Precise Nitinol Stent System
- FDA Device
- Class II
- ongoing
- Published 2020-01-01
On 2020-01-01 the FDA classified a Class II recall of Cordis Precise Nitinol Stent System by Cardinal Health, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0729-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-11-14 |
| Published | 2020-01-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cardinal Health |
| Distribution | US |
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
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".
Identifiers
| code_info | All Lot Codes. Affected SKUs: N1020SB, N1020SB, N1020SC, N1030SB, N1030SB, N1030SC, N1040SB, N1040SB, N1040SC, N520SB…All Lot Codes. Affected SKUs: N1020SB, N1020SB, N1020SC, N1030SB, N1030SB, N1030SC, N1040SB, N1040SB, N1040SC, N520SB, N520SC, N530SB, N530SC, N540SB, N540SC, N620SB, N620SC, N630SB, N630SC, N640SB, N640SC, N720SB, N720SC, N730SB, N730SC, N740SB, N740SC, N820SB, N820SB, N820SC, N830SB, N830SB, N830SC, N840SB, N840SB, N840SC, N920SB, N920SB, N920SC, N930SB, N930SB, N930SC, N940SB, N940SB, N940SC, P05020RXB, P05030RXB, P05040RXB, P0520RXCE, P0530RXCE, P0540RXCE, P06020RXB, P06030RXB, P06040RXB, P0620RXCE, P0630RXCE, P0640RXCE, P07020RXB, P07030RXB, P07040RXB, P0720RXCE, P0730RXCE, P0740RXCE, P08020RXB, P08030RXB, P08040RXB, P0820RXCE, P0830RXCE, P0840RXCE, P09020RXB, P09030RXB, P0920RXCE, P0930RXCE, P0940RXCE, P10020RXB, P1020RXCE, P1030RXCE, P1040RXCE. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0729-2020%22
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