Cordis Vascular Stent System Recalled Due to Incorrect Product Size
Cordis US Corp recalls Smart Control Vascular Stent System ILIAC devices due to product mix-up where some units are labeled 9mm X 60mm but contain different stent sizes. Patients should consult their healthcare provider immediately.
What this means for you
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: This is an FDA Class II medical device recall with no reported illnesses or injuries. However, the size mismatch in a vascular stent represents a risk-of-harm product where injury has not yet been reported, as incorrect stent dimensions could cause serious vascular complications.
Plain-English summary
Cordis US Corp is recalling certain Smart Control Vascular Stent System ILIAC devices (Reference C09060ML) because of a product mix-up: some units are labeled as 9mm X 60mm but contain vascular stents of a different size. This size discrepancy could result in improper stent placement and vascular complications.
The recalled devices were distributed to hospitals and healthcare facilities in Arkansas, Arizona, Florida, New Jersey, Tennessee, and Japan. The affected lot number is 18298568 (UDI: 01-20705032024430). The recalled devices are prescription-only medical devices supplied as single sterile units.
Healthcare providers and patients who have received these devices should immediately contact Cordis US Corp for instructions. Patients should ensure their healthcare provider verifies the actual stent size before any implantation.
The recalled product
- Product
- Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only
- Manufacturer
- Cordis US Corp
- Category
- Medical Device — Vascular Stent
- Affected units
- 1
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 # 18298568/UDI:(01)20705032024430
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.
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