FDA Recalls iCast Covered Stent System Due to Device Separation During Delivery
Atrium Medical is recalling the iCast Covered Stent System because the balloon or catheter hub may separate from the delivery catheter during use, potentially causing blood clots, vessel blockages, or organ damage.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I classification applies to this recall, which automatically qualifies as Critical severity. The defect involves mechanical failure of a critical vascular delivery system that can result in serious vascular complications including thrombosis, organ ischemia, and amputation. The June 2023 update to the recall identified potential for myocardial infarction or death from extended surgical intervention.
Plain-English summary
Atrium Medical Corporation is recalling the iCast Covered Stent System, a medical device used in vascular interventional procedures. The recall affects 68,812 units across multiple product codes and sizes, distributed internationally to countries including Australia, Canada, France, Germany, Japan, and many others.
The company has identified an increased rate of complaints in which the balloon or catheter hub separates from the delivery catheter during device withdrawal. This separation can cause procedural delays and may require additional anesthesia and contrast media, with potential impact to kidney function.
The potential complications from this defect include blood vessel occlusion, embolism, amputation, loss of organ function, organ infarction, and tissue infarction. According to an FDA update issued in June 2023, prolonged surgical intervention needed to manage these complications could lead to myocardial infarction or death.
Patients who have received this device should consult with their healthcare provider. Healthcare providers should contact Atrium Medical Corporation for guidance regarding affected devices in their inventory.
The recalled product
- Product
- iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408 85409 85410 85411 85412 85413 85414 85415 85416 85417 85418 85419 85420 85424 85440 85441 85442 85443 85444 85445 85450 85451 85452 85453…
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Stent
- Affected units
- 68,812
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)
- All lots
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Atrium Medical Corporation 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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