Atrium Medical Corporation 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 85454 85455 Product Code/UDI /Description: 85400 00650862854008 iCAST COVERED STENT,5MMX38MMX80CM 85401 00650862854015 iCAST COVERED STENT,5MMX59MMX80CM 85402 00650862854022 iCAST COVERED STENT,6MMX38MMX80CM 85403 00650862854039 iCAST COVERED STENT,6MM Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal causing procedural delay and possible administration of additional anesthesia and contrast which may impact patients' renal function. Potential harms include occlusion or embolism and associated response, with specific outcomes such as amputation, embolism, loss of organ function, organ infarction, or tissue infarction. ***Updated June 2023*** Additional surgical stress caused by prolonged interventional surgery has the potential to lead to myocardial infarction or death.

Recommended Action

Per FDA guidance

Atrium/Getinge issued Urgent Field Safety Notification to Hospitals (OUS) via on 3/03/22 via email. Letter states reason for recall, health risk and action to take: The company is updating the Advanta V12 Covered Stent System Instructions for Use (IFU). REVISED: Deflation and Withdrawal Instructions: Deflate balloon by pulling vacuum on the inflation device to its maximum volume and allow sufficient time for full deflation. IMPORTANT: Visually verify full deflation of the balloon via fluoroscopy before attempting to withdraw the delivery system. You may continue to use the Advanta V12 Covered Stent Systems, with the consideration of this revised information, which is included on the following page. No Devices Need to Be Returned. If you have any questions, please contact your local Getinge representative. ***UPDATE APRIL 2022*** On April 22, 2022, the firm expanded its recall to include the iCast Covered Stent System. If the device is inflated/deflated using higher concentrations of contrast media or other viscous fluid, as may occur in off-label endovascular procedures, a balloon may take longer to deflate than prescribed in the iCast IFU. Letters were issued to consignees via FedEx with delivery receipt. Customers were informed they may continue to use the iCast covered stent with the consideration of the Deflation and Withdrawal Instructions when used for endovascular procedures. ***UPDATE JUNE 2023*** On June 13, 2023, the firm sent an updated letter to customers to reflect an updated Risk to Health due to new complaint data. ALL LOTS of product, including lots manufactured after May 2020, are affected.