CLASS II ONGOING Device recall · Reported 16 Oct 2024 · FDA Enforcement Report
iCast Covered Stent, 6MMx16MMx120CM recalled by Atrium Medical
Atrium Medical is recalling iCast Covered Stent, 6MMx16MMx120CM, distributed nationwide in the US. The recall was initiated on 9 Sep 2024 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-0024-2025
- FDA event ID
- 95329
- Recalling firm
- Atrium Medical, Merrimack, NH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Sep 2024
- FDA classified
- 7 Oct 2024
- Reported
- 16 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 9 Sep 2024 | Recall initiated by company | |
| 7 Oct 2024 | Classified by FDA | +28 days |
| 16 Oct 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
Product as listed by the FDA
iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Where it was distributed
US Nationwide distribution in the states of FL, MA, MI, OH, WA.
Questions about this recall
Why was it recalled?
There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
Which lots are affected?
UDI-DI: 00650862426168; Lot Number: 508083; Serial Numbers: 508083031, 508083032, 508083034, 508083035, 508083036, 508083037, 508083038, 508083039, 508083040, 508083041, 508083042
Where was it sold?
US Nationwide distribution in the states of FL, MA, MI, OH, WA.
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.
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