Cordis Precise Nitinol Stent System Labeling Correction for MRI Information
Cardinal Health is correcting labeling on Cordis Precise Nitinol Stent Systems because the instructions incorrectly stated the device was MRI Safe instead of MRI Conditional.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a labeling error (FDA Class II) where the hazard is theoretical (incorrect MRI safety classification) and no illnesses or injuries are reported, fitting the Moderate criteria for minor labeling errors or low-risk issues.
Plain-English summary
Cardinal Health Inc. has initiated a labeling correction for the Cordis Precise Nitinol Stent System. The recall addresses incorrect MRI information found on the Instructions for Use (IFU). The device is a self-expanding endoluminal stent designed for the carotid vasculature.
The specific issue is that the IFU incorrectly classified the device as "MRI Safe." The correct classification is "MRI Conditional." This correction ensures that healthcare providers and patients have accurate information regarding the safety of the device during magnetic resonance imaging procedures.
The recall affects 267,247 units distributed worldwide, including 4,606 units in the United States. Affected SKUs include various N-series and P-series codes. Consumers and healthcare providers should refer to the corrected labeling for accurate MRI safety information.
The recalled product
- 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…
- Manufacturer
- Cardinal Health Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- All Lot Codes. Affected SKUs: N1020SB
- N1020SB
- N1020SC
- N1030SB
- N1030SC
- N1040SB
- N1040SC
- N520SB
- N520SC
- N530SB
- N530SC
- N540SB
- N540SC
- N620SB
- N620SC
- N630SB
- N630SC
- N640SB
- N640SC
- N720SB
Distribution
Part of a larger recall action
This product is one of 3 recalled by Cardinal Health Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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