Recall Z-1077-2022 ยท JCT Prosthesis, Tracheal, Expandable
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
| Date | May 18, 2022 (initiated Mar 3, 2022) |
| Status | Open, Classified |
| Reason | 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 poten |
| Root cause | Device Design |
| Action | 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 Cover |
| Quantity | 68812 units |
| Distribution | Foreign: Australia Austria Bahrain Belgium Bosnia-Herzegovina Brazil Bulgaria Canada Chile Colombia Costa Rica Cyprus Czech Republic Denmark Ecuador Egypt El Salvador Estonia Finland France Germany Great Britain Greece Hong Kong Hungary Iceland Ireland, Republic of Israel Italy Japan Jordan Kuwait L |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050814 | ATRIUM ICAST COVERED STENT Atrium Medical Corp., May 6, 2005 |