# FDA recall Z-1077-2022

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

## Product

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,5MMX59MMX12

## 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-1077-2022
- **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-1077-2022

## Citation

> AI Analytics. FDA recall Z-1077-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1077-2022. Source: US FDA. Licensed CC0.

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