iCast Covered Stent System recall
iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408 85409 85410 85411 85412 85413 85414 85415…
Why was iCast Covered Stent System recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots
- 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…
- Recalling firm
- Atrium Medical Corporation
- Quantity
- 68812 units
- 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
- Recall date
- May 25, 2022
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)