Use caution Medical device recall · FDA · Published March 3, 2022

Atrium Advanta V12 Stent System Recall: Risk of Stent Separation During Procedure

Atrium Medical recalls specific stent models due to increased risk of balloon or catheter hub separation during delivery, potentially causing procedural delays, additional anesthesia, and kidney damage. Affected products include 85320-85398 series.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1076-2022Medical device Atrium Medical ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmAtrium Medical Corporation40 Continental Blvd · Merrimack, NH 03054-4332

✎ GovInfoNow plain-language explainer

Atrium Medical is recalling certain covered stent systems used in medical procedures because they can separate during delivery, causing delays and potential kidney damage. This risk may lead to serious complications like organ damage or amputation. Read more at govinfonow.com/recall/61000-atrium-advanta-v12-stent-system-recall-risk-of-stent-separation.

Source Summary by GovInfoNow · govinfonow.com/recall/61000-atrium-advanta-v12-stent-system-recall-risk-of-stent-separation · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1076-2022

Cite this page

“Atrium Advanta V12 Stent System Recall: Risk of Stent Separation During Procedure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61000-atrium-advanta-v12-stent-system-recall-risk-of-stent-separation. Based on FDA recall #Z-1076-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1076-2022%22&limit=1).

The FDA announced on March 3, 2022, that Atrium Medical Corporation is recalling the Advanta V12 Covered Stent System due to a potential separation of the balloon or catheter hub during withdrawal. The agency classified the recall as Class I.

How to tell if you have it

Brand: Atrium Medical
Product: Atrium Advanta V12 Covered Stent System (OUS only)
Part Numbers: 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, 85370, 85371, 85372, 85379, 85388, 85390, 85391, 85392, 85394, 85395, 85396, 85397, 85398
Quantity: 105,968 units
Distribution: 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, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Malta, Mexico, Netherlands, New Zealand, Norway, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russia, San Marino, Saudi Arabia, Singapore, Slovak Republic, Slovenia, South African Republic, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, Uruguay, Vietnam
Lots: All lots

The hazard

The firm observed an increased rate of complaints regarding the separation of the balloon or catheter hub from the delivery catheter during withdrawal. This defect can cause procedural delays and may lead to occlusion, embolism, amputation, loss of organ function, organ infarction, or tissue infarction. An update in June 2023 noted that prolonged surgery caused by this issue could potentially lead to myocardial infarction or death.

Context

GovInfoNow's records show Atrium Medical Corporation has 16 other recalls on record since November 22, 2017. Other recent recalls of similar products include Getinge Thoracic Catheter Recall (August 7, 2026), Medtronic DLP Retrograde Cannula Recall (April 21, 2026), Medline Urethral Catheter Tray Recall (May 4, 2026), and Merit Medical Allwell Angioplasty Pack Recall (December 4, 2025).

How to tell if you have this one

Check for product codes 85320 through 85398 in the list provided by Atrium Medical. These stents are used in medical procedures and are only available for OUS (Outpatient Surgical) settings.

Brand
Atrium Medical
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Ongoing
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 Latvia Lebanon Lithuania Macedonia Malaysia Malta Mexico Netherlands New Zealand Norway Panama Paraguay Peru Philippines Poland Portugal Qatar Reunion Russia San Marino Saudi Arabia Singapore Slovak Republic Slovenia South African Republic South Korea Spain Sweden Switzerland Taiwan, Thailand Trinidad and Tobago Turkey United Arab Emirates Uruguay Vietnam

Recall number	Product, codes & lots	Quantity
Z-1076-2022	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; All lots	105,968 units
Z-1077-2022	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; All lots	68812 units

Based on the official FDA remedy

What to do — step by step

Check Product Codes
Review the product codes listed (85320-85398) to confirm if your stent system is affected.

How this recall unfolded

Recall timeline

FDA published this recall 3 months after the firm started it.

Mar 3, 2022Firm started the recall
May 18, 2022FDA classified it Class I
May 25, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/61000-atrium-advanta-v12-stent-system-recall-risk-of-stent-separation">Atrium Advanta V12 Stent System Recall: Risk of Stent Separation During Procedure (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1076-2022 (March 3, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1076-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.