Prosthesis, Tracheal, Expandable

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2022-05-18Open, ClassifiedDevice Design

  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/UDI /Description: 85320 650862853209 Advanta V12 Covered Stent, 5mm x 38mm x 80cm; 85321 650862853216 Advanta V12 Covered Stent, 5mm x 59mm x 80cm; 85322 650862853223 Advanta V12 Covered Stent, 6mm x 38mm x 80cm; 85323 650862853230 Advanta V12 Covered Stent, 6mm x 59mm x 80cm 85324 650862853247 Advanta V12 Covered Stent, 7mm x 38mm x 80cm; 85325 650862853254 Advanta V12 Covered Stent, 7mm x 59mm x 80cm; 85326 650862853261 Advanta V12 Covered Stent, 8mm x 38mm x 80cm; 85327 650862853278 Advanta V12 Covered Stent, 8mm x 59mm x 80cm; 85328 650862853285 Advanta V12 Covered Stent, 9mm x 38mm x 80cm; 85329 650862853292 Advanta V12 Covered Stent, 9mm x 59mm x 80cm; 85330 650862853308 Advanta V12 Covered Stent, 5mm x 38mm x120cm; 85331 650862853315 Advanta V12 Covered Stent, 5mm x 59mm x120cm; 85332 650862853322 Advanta V12 Covered Stent, 6mm x 38mm x120cm; 85333 650862853339 Advanta V12 Covered Stent, 6mm x 59mm x120cm; 85334 650862853346 Advanta V12 Covered Stent, 7mm x 38mm x120cm; 85335 650862853353 Advanta V12 Covered Stent, 7mm x 59mm x120cm; 85336 650862853360 Advanta V12 Covered Stent, 8mm x 38mm x120cm; 85337 650862853377 Advanta V12 Covered Stent, 8mm x 59mm x120cm; 85338 650862853384 Advanta V12 Covered Stent, 9mm x 38mm x120cm; 85339 650862853391 Advanta V12 Covered Stent, 9mm x 59mm x120cm; 85340 650862853407 Advanta V12 Covered Stent, 5mm x 16mm x 80cm; 85341 650862853414 Advanta V12 Covered Stent, 5mm x 22mm x 80cm; 85342 650862853421 Advanta V12 Covered Stent, 6mm x 16mm x 80cm; 85343 650862853438 Advanta V12 Covered Stent, 6mm x 22mm x 80cm; 85344 650862853445 Advanta V12 Covered Stent, 7mm x 16mm x 80cm; 85345 650862853452 Advanta V12 Covered Stent, 7mm x 22mm x 80cm; 85350 650862853506 Advanta V12 Covered Stent, 5mm x 16mm x 120cm; 85351 650862853513 Advanta V12 Covered Stent, 5mm x 22mm x 120cm; 85352 650862853520 Advanta V12 Covered Stent, 6mm x 16mm x 120cm; 85353 650862853537 Advanta V12 Covered Stent, 6mm x 22mm x 120cm; 85354 650862853544 Advanta V12 Covered Stent, 7mm x 16mm x 120cm; 85355 650862853551 Advanta V12 Covered Stent, 7mm x 22mm x 120cm; 85360 650862853605 Advanta V12 Covered Stent, 10mm x 38mm x 80cm; 85361 650862853612 Advanta V12 Covered Stent, 10mm x 59mm x 80cm; 85364 650862853643 Advanta V12 Covered Stent, 10mm x 38mm x 120cm; 85365 650862853650 Advanta V12 Covered Stent, 10mm x 59mm x 120cm; 85370 650862853704 Advanta V12 Large Diameter, 12mm x 29mm x 80cm; 85371 650862853711 Advanta V12 Large Diameter, 12mm x 41mm x 80cm; 85372 650862853728 Advanta V12 Large Diameter, 12mm x 61mm x 80cm; 85379 650862853797 Advanta V12 Large Diameter, 12mm x 29mm x 120cm; 85388 650862853889 Advanta V12 Covered Stent, 5mm x 32mm x 80cm; ;85390 650862853902 Advanta V12 Covered Stent, 7mm x 32mm x 80cm; 85391 650862853919 Advanta V12 Covered Stent, 8mm x 32mm x 80cm; 85392 650862853926 Advanta V12 Covered Stent, 9mm x 32mm x 80cm; 85394 650862853940 Advanta V12 Covered Stent, 5mm x 32mm x 120cm; 85395 650862853957 Advanta V12 Covered Stent, 6mm x 32mm x 120cm. 85396 650862853964 Advanta V12 Covered Stent, 7mm x 32mm x 120cm 85397 650862853971 Advanta V12 Covered Stent, 8mm x 32mm x 120cm 85398 650862853988 Advanta V12 Covered Stent, 9mm x 32mm x 120cm

  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.

• 2022-05-18Open, ClassifiedDevice Design

  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,6MMX59MMX80CM 85404 00650862854046 iCAST COVERED STENT,7MMX38MMX80CM 85405 00650862854053 iCAST COVERED STENT,7MMX59MMX80CM 85406 00650862854060 iCAST COVERED STENT,8MMX38MMX80CM 85407 00650862854077 iCAST COVERED STENT,8MMX59MMX80CM 85408 00650862854084 iCAST COVERED STENT,9MMX38MMX80CM 85409 00650862854091 iCAST COVERED STENT,9MMX59MMX80CM 85410 00650862854107 iCAST COVERED STENT,5MMX38MMX120CM 85411 00650862854114 iCAST COVERED STENT,5MMX59MMX120CM 85412 iCAST COVERED STENT,6MMX38MMX120CM 85413 00650862854138 iCAST COVERED STENT,6MMX59MMX120CM 85414 00650862854145 iCAST COVERED STENT,7MMX38MMX120CM 85415 00650862854152 iCAST COVERED STENT,7MMX59MMX120CM 85416 00650862854169 iCAST COVERED STENT,8MMX38MMX120CM 85417 00650862854176 iCAST COVERED STENT,8MMX59MMX120CM 85418 00650862854183 iCAST COVERED STENT,9MMX38MMX120CM 85419 00650862854190 iCAST COVERED STENT,9MMX59MMX120CM 85420 00650862854206 iCAST COVERED STENT,10MMX38MMX80CM 85424 00650862854244 iCAST COVERED STENT,10MMX38MMX120CM 85440 00650862854404 iCAST COVERED STENT,5MMX16MMX80CM 85441 00650862854411 iCAST COVERED STENT,5MMX22MMX80CM 85442 00650862854428 iCAST COVERED STENT 6MMX16MMX80CM 85443 00650862854435 iCAST COVERED STENT,6MMX22MMX80CM 85444 00650862854442 iCAST COVERED STENT,7MMX16MMX80CM 85445 00650862854459 iCAST COVERED STENT,7MMX22MMX80CM 85450 00650862854503 iCAST COVERED STENT,5MMX16MMX120CM 85451 00650862854510 iCAST COVERED STENT,5MMX22MMX120CM 85452 00650862854527 iCAST COVERED STENT,6MMX16MMX120CM 85453 00650862854534 iCAST COVERED STENT,6MMX22MMX120CM 85454 00650862854541 iCAST COVERED STENT,7MMX16MMX120CM 85455 00650862854558 iCAST COVERED STENT,7MMX22MMX120CM

  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.

• 2017-07-07TerminatedUnder Investigation by firm

  Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only) Atrium Advanta V12 Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85355 (Marketed OUTSIDE U.S. only) The iCAST Covered Stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.

  Firm received a complaint that a customer who ordered an ADVANTA V12 7mm x 22mm x 120cm received an ADVANTA v12 7 mm x 38 mm x 80 cm, due to the manifold (catheter hub) was printed as 7mm x 38 mm x 80 cm. The complaint was the result of incorrect dimensional information (7mm x 38mm x 80cm) printed on the manifiold (catheter hub). The complaint device physical dimensions matched the dimensional information displayed on the outer packaging and the device inner pouch. This was the only complaint received for this non-conformance.

• 2015-07-24TerminatedOther

  Medical Device Exchange 12x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-212; EXP (repackager), Aero (OEM) Prosthesis, tracheal, expandable

  EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

• 2015-07-24TerminatedOther

  Medical Device Exchange 10x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-209; EXP (repackager), Aero (OEM) Prosthesis, tracheal, expandable

  EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

• 2015-07-24TerminatedOther

  Medical Device Exchange Aerosizer Stent Sizing Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-501. EXP (repackager), Merit Medical (OEM) Prosthesis, tracheal, expandable

  EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

• 2011-07-15TerminatedLabeling False and Misleading

  Boston Scientific, WALLSTENT" Endoprosthesis & WALLSTENT" RP Endoprosthesis, Self Expanding Stent, Stent Auto-expanisvel, Made in Ireland, Ballybrit Business Park, Galway, IRELAND, STERILE, EO. Indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms. WALLSTENT" Endoprosthesis Material Catalog # Description H965402100 40210 12X20/8FR UNI PLUS HALO 100CM H965402110 40211 12X40/8FR UNI PLUS HALO 100CM H965402120 40212 12X60/8FR UNI PLUS HALO 100CM H965402130 40213 12X90/8FR UNI PLUS HALO 100CM H965403100 40310 14X20/9FR UNI PLUS HALO 100CM H965403110 40311 14X40/9FR UNI PLUS 100CM H965403120 40312 14X60/9FR UNI PLUS 100CM H965403130 40313 14X90/9FR UNI PLUS 100CM H965403300 40330 16X20/9FR UNI PLUS 100CM H965403310 40331 16X40/9FR UNI PLUS 100CM H965403320 40332 16X60/9FR UNI PLUS 100CM H965403330 40333 16X90/9FR UNI PLUS 100CM H965404110 40411 18X40/10FR UNI PLUS 100CM H965404120 40412 18X60/10FR UNI PLUS 100CM H965404130 40413 18X90/10FR UNI PLUS 100CM H965404300 40430 20X40/10FR UNI PLUS 100CM H965404310 40431 20X55/10FR UNI PLUS 100CM H965404320 40432 20X80/10FR UNI PLUS 100CM H965404500 40450 22X35/10FR UNI PLUS 100CM H965404510 40451 22X45/10FR UNI PLUS 100CM H965404520 40452 22X70/10FR UNI PLUS 100CM H965405100 40510 24X35/11FR UNI PLUS 100CM H965405110 40511 24X45/11FR UNI PLUS 100CM H965405120 40512 24X70/11FR UNI PLUS 100CM H965412000 41200 12X20/135CM 8FR BARE UNI + HALO 160CM H965412010 41201 12X40/135CM 8FR BARE UNI + HALO 160CM H965412020 41202 12X60/135CM 8FR BARE UNI + HALO 160CM H965412030 41203 12X90/135CM 8FR BARE UNI + HALO 160CM WALLSTENT" RP Endoprosthesis Material Catalog # Description M001711000 71-100 5x20x75/ 6F Unistep Plus M001711010 71-101 5x20x135/ 6F Unistep Plus M001711020 71-102 5x40x75/ 6F Unistep Plus M001711030 71-103 5x40x135/ 6F Unistep Plus M001711040 71-104 5x55x75/ 6F Unistep Plus M001711050 71-105 5x55x135/ 6F Unistep Plus M001711060 71-106 5x80x75, 6F Unistep Plus M001711080 71-108 6x20x75/ 6F Unistep Plus M001711090 71-109 6x20x135/ 6F Unistep Plus M001711100 71-110 6x45x75/ 6F Unistep Plus M001711110 71-111 6x45x135/ 6F Unistep Plus M001711120 71-112 6x60x75/ 6F Unistep Plus M001711130 71-113 6x60x135/ 6F Unistep Plus M001711140 71-114 6x90x75/ 6F Unistep Plus M001711150 71-115 6x90x135/ 6F Unistep Plus M001711160 71-116 7x20x75/ 6F Unistep Plus M001711160 71-116 7x20x75/ 6F Unistep Plus M001711170 71-117 7x20x135/ 6F Unistep Plus M001711180 71-118 7x40x75/ 6F Unistep Plus M001711190 71-119 7x40x135/ 6F Unistep Plus M001711200 71-120 7x60x75/ 6F Unistep Plus M001711210 71-121 7x60x135/ 6F Unistep Plus M001711220 71-122 7x90x75/ 6F Unistep Plus M001711230 71-123 7x90x135/ 6F Unistep Plus M001711240 71-124 8x20x75/ 6F Unistep Plus M001711250 71-125 8x20x135/ 6F Unistep Plus M001711260 71-126 8x40x75/ 6F Unistep Plus M001711270 71-127 8x40x135/ 6F Unistep Plus M001711280 71-128 8x60x75/ 6F Unistep Plus M001711290 71-129 8x60x135/ 6F Unistep Plus M001711300 71-130 8x80x75/ 6F Unistep Plus M001711310 71-131 8x80x135/ 6F Unistep Plus M001711320 71-132 10x20x75/ 6F Unistep Plus M001711330 71-133 10x20x135/ 6F Unistep Plus M001711340 71-134 10x42x75/ 7F Unistep Plus M001711350 71-135 10x42x135/ 7F Unistep Plus M001711360 71-136 10x68x75/ 7F Unistep Plus M001711370 71-137 10x68x135/ 7F Unistep Plus M001711380 71-138 10x94x75/ 7F Unistep Plus M001711390 71-139 10x94x135/ 7F Unistep Plus

  Boston Scientific is initiating an important field correction related to WALLSTENT", WALLSTENT" RP, and WALLGRAFT Tracheobronchial Endoprosthesis products. This letter is intended to clarify and re-emphasize that U.S. WALLSTENT", WALLSTENT" RP, and WALLGRAFT Tracheobronchial Endoprosthesis stents are NOT currently cleared by the FDA for use in benign tracheobronchial strictures.

• 2011-07-15TerminatedLabeling False and Misleading

  Boston Scientific, WALLGRAFT OVER-THE-WIRE, Tracheobronchial Endoprosthesis, Made in IRELAND, Ballybrit Business Park, Galway, IRELAND, STERILE, EO. The WALLGRAFT Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms. Material Catalog # Description M001705020 70-502 WALLGRAFT PKG T/B/10X20 10FR COMML M001705030 70-503 WALLGRAFT PKG T/B/10X30 10FR COMML M001705050 70-505 WALLGRAFT PKG T/B/10X50 10FR COMML M001705070 70-507 WALLGRAFT PKG T/B/10X70 10FR COMML M001705230 70-523 WALLGRAFT PKG T/B/12X30 11FR COMML M001705250 70-525 WALLGRAFT PKG T/B/12X50 11FR COMML M001705270 70-527 WALLGRAFT PKG T/B/12X70 11FR COMML M001705450 70-545 WALLGRAFT PKG T/B 14X50 12 FR M001705470 70-547 WALLGRAFT PKG T/B 14X70 12FR M001705620 70-562 WALLGRAFT PKG T/B/6X20 9FR COMML M001705630 70-563 WALLGRAFT PKG T/B/6X30 9FR COMML M001705650 70-565 WALLGRAFT PKG T/B/6X50 9FR COMML M001705670 70-567 WALLGRAFT PKG T/B/6X70 9FR COMML M001705720 70-572 WALLGRAFT PKG T/B/7X20 9FR COMML M001705730 70-573 WALLGRAFT PKG T/B/7X30 9FR COMML M001705750 70-575 WALLGRAFT PKG T/B/7X50 9FR COMML M001705770 70-577 WALLGRAFT PKG T/B/7X70 9FR COMML M001705820 70-582 WALLGRAFT PKG T/B/8X20 9FR COMML M001705830 70-583 WALLGRAFT PKG T/B/8X30 9FR COMML M001705850 70-585 WALLGRAFT PKG T/B/8X50 9FR COMML M001705870 70-587 WALLGRAFT PKG T/B/8X70 9FR COMML M001705920 70-592 WALLGRAFT PKG T/B/9X20 10FR COMML M001705930 70-593 WALLGRAFT PKG T/B/9X30 10FR COMML M001705950 70-595 WALLGRAFT PKG T/B/9X50 10FR COMML M001705970 70-597 WALLGRAFT PKG T/B/9X70 10FR COMML

  Boston Scientific is initiating an important field correction related to WALLSTENT", WALLSTENT" RP, and WALLGRAFT Tracheobronchial Endoprosthesis products. This letter is intended to clarify and re-emphasize that U.S. WALLSTENT", WALLSTENT" RP, and WALLGRAFT Tracheobronchial Endoprosthesis stents are NOT currently cleared by the FDA for use in benign tracheobronchial strictures.

• 2010-08-31TerminatedProcess control

  Boston Scientific Ultraflex Uncovered Tracheobronchial Stent System - Proximal Release (10/4) Material/UPN/Catalog Number: M00564670

  Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment.

• 2010-08-31TerminatedProcess control

  Boston Scientific Ultraflex Covered Tracheobronchial Stent System -- Distal Release (10/4/2.5) Material/UPN/Catalog Number: M00564760

  Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment.