Cordis Smart Control Vascular Stent Size Mismatch Recalled
Cordis recalled 20 units of its Smart Control Vascular Stent System ILIAC due to a labeling mix-up where the external label does not match the actual stent size. Wrong-sized stents could cause serious vessel complications if implanted.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a medical device with a product size mismatch that poses a risk of serious harm (incorrect stent implantation could cause vessel damage or thrombosis). No hospitalizations or injuries have been reported, meeting the criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cordis US Corp has recalled 20 units of the Smart Control Vascular Stent System ILIAC, 10mm X 40mm, due to a product mix-up in which the stent's external labeling does not match the actual size of the device inside. The affected lot is 18298569. This labeling discrepancy poses a risk if a healthcare provider relies on the external label and implants a stent of incorrect size, which could compromise vessel integrity and patient safety.
The recalled stents were distributed to hospitals and healthcare facilities in Arkansas, Arizona, Florida, New Jersey, and Tennessee within the United States, as well as to facilities in Japan.
Healthcare providers who have received this product should immediately verify the actual stent size before implantation. Any providers who may have already implanted these stents should contact Cordis US Corp immediately to determine if corrective action is needed for affected patients.
The recalled product
- Product
- Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
- Manufacturer
- Cordis US Corp
- Category
- Medical Device — Vascular Stent
- Affected units
- 20
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 (1)
- Lot: 18298569/UDI: (01)20705032024591
Distribution
Part of a larger recall action
This product is one of 2 recalled by Cordis US Corp 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.
See all 2 products in this recall →Related recalls
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