Reported May 25, 2022 · Ongoing
iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408 85409 85410…
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?
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
33 of 33 products
| Model / number | Barcodes | Product as published |
|---|---|---|
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 |
- Lot codes and dates
- All lots
- Amount recalled
- 68812 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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