# FDA recall Z-1076-2022

> **Atrium Medical Corporation** · Class I · device recall initiated 2022-03-03.

## Product

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

## Reason for recall

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.

## 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

## Key facts

- **Recall number:** Z-1076-2022
- **Recalling firm:** Atrium Medical Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-03
- **Report date:** 2022-05-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Merrimack, NH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1076-2022

## Citation

> AI Analytics. FDA recall Z-1076-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1076-2022. Source: US FDA. Licensed CC0.

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