Product Safety Recalls

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Atrium Medical Corporation Recall 89852

Description: 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

Atrium Medical Corporation Recall 89852 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1077-2022
Event ID89852
Event DescriptioniCast 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
Product TypeDevices
DistributionForeign: 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
Quantity68812 units
Recall ReasonFirm 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.
Device Classification20220525
Device Code InfoAll lots
Center Classification Date20220518
Recall Initiation Date20220303
Recalling FirmAtrium Medical Corporation
Initial Notification E-Mail
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