The Recall Desk
CriticalFDA (Devices)·Z-1077-2022·Announced 2022-05-25

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.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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
Hazard
  • device-separation
  • occlusion
  • embolism
  • myocardial-infarction

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.

Related recalls

Same category