CLASS II ONGOING Device recall · Reported 9 Apr 2025 · FDA Enforcement Report
Cordis, REF: C09060ML, Smart Control Vascular Stent System recalled
Cordis US is recalling Cordis, REF: C09060ML, Smart Control Vascular Stent System Iliac, 9mm, distributed in Arkansas, Arizona, Florida, New Jersey, Tennessee. The recall was initiated on 4 Mar 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1511-2025
- FDA event ID
- 96418
- Recalling firm
- Cordis US, Miami Lakes, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Mar 2025
- FDA classified
- 3 Apr 2025
- Reported
- 9 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 4 Mar 2025 | Recall initiated by company | |
| 3 Apr 2025 | Classified by FDA | +30 days |
| 9 Apr 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
product mix-up; Vascular stent labeled as one size but contains a different size.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only
Where it was distributed
US Distribution to states of: AR, AZ, FL, NJ, TN; and OUS Foreign country of: Japan
Questions about this recall
Why was it recalled?
product mix-up; Vascular stent labeled as one size but contains a different size.
Which lots are affected?
Lot # 18298568/UDI:(01)20705032024430
Where was it sold?
US Distribution to states of: AR, AZ, FL, NJ, TN; and OUS Foreign country of: Japan
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 96418This product is part of a recall event; the main page for the event is Cordis, REF C10040ML, Smart Control Vascular Stent System recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Cordis, REF C10040ML, Smart Control Vascular Stent System recalled | Cordis US | Packaging Defects | 5 states |
More recalls from Cordis US
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Cordis, REF C10040ML, Smart Control Vascular Stent System recalled | Cordis US | Packaging Defects | 5 states |
| Device | CLASS II | Vista Brite Tip, Judkins Right recalled by Cordis US | Cordis US | Other | WA |
| Device | CLASS II | Mynxgrip 6f/7f recalled by Cordis US | Cordis US | Packaging Defects | 7 states |
| Device | CLASS II | Mynxgrip 5F recalled by Cordis US | Cordis US | Packaging Defects | 7 states |
| Device | CLASS I | Cordis Angiographic Catheterization Sets, Infiniti Thrulemen, 5F recalled | Cordis US | Sterility | OK |
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| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |