Recall Z-1076-2022 ยท JCT Prosthesis, Tracheal, Expandable
Atrium Medical Corporation
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 85361 85364 85365 85388 85389 85390 85391 85392 85394 85395 85396 85397 85398 85370 85371 85372 and 85379. Product Code/UD
| 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 | 105,968 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
This recall record lists no 510(k) number.