The Recall Desk
SevereFDA (Devices)·Z-1076-2022·Announced 2022-05-25

Atrium Advanta V12 Covered Stent System Recalled for Delivery Catheter Separation

Atrium Medical is recalling the Advanta V12 Covered Stent System worldwide for potential separation of the balloon or catheter hub during withdrawal, which may cause procedural delays and serious complications including embolism and organ infarction.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall, which mandates a minimum severity score of 4. The defect involves potential for serious complications including embolism, organ infarction, amputation, and myocardial infarction, though no specific illnesses or deaths have been reported. The potential for fatal outcomes justifies the Severe classification.

Plain-English summary

Atrium Medical Corporation is recalling the Advanta V12 Covered Stent System (all lots) from outside the United States due to a defect in the delivery system. The system is used in vascular interventions, with multiple configurations ranging from 5mm to 12mm in diameter and 16mm to 120cm in length.

The company has received an increased rate of customer complaints reporting that the balloon or catheter hub separates from the delivery catheter during the withdrawal phase. This separation causes procedural delays and may necessitate additional anesthesia and contrast administration, which can impact patient renal function.

Potential complications from the separation include occlusion, embolism, amputation, loss of organ function, organ infarction, and tissue infarction. An FDA update issued in June 2023 noted that prolonged surgical time caused by the defect could additionally lead to myocardial infarction or death.

Approximately 105,968 units were distributed to medical facilities in countries outside the United States. Healthcare providers should immediately quarantine affected products and contact Atrium Medical Corporation for remediation options.

The recalled product

Product
Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328 85329 85330 85331 85332 85333 85334 85335 85336 85337 85338 85339 85340 85341 85342 85343 85344 85345 85350 85351 85352 85353 85354 85355 85360
Manufacturer
Atrium Medical Corporation
Category
Medical Device — Vascular Stent System
Hazard
  • catheter-separation
  • embolism
  • organ-infarction
  • 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