Reported May 25, 2022 · Ongoing
Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326…
Atrium Medical Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Atrium Medical Corporation · 40 Continental Blvd · Merrimack, NH · 03054-4332
Is this the product you have?
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
48 of 48 products
| Model / number | Barcodes | Product as published |
|---|---|---|
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 |
- Lot codes and dates
- All lots
- Amount recalled
- 105,968 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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