Atrium Medical recalls iCast Covered Stent Systems with specific product codes due to risk of balloon or catheter hub separation during delivery, potentially causing procedural delays, additional anesthesia, and kidney damage.
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.
Atrium Medical is recalling iCast Covered Stent Systems with product codes 85400-85455. The stents can separate during delivery, causing procedural delays and potential kidney damage or other serious complications.
The stent system can separate during delivery, causing procedural delays and requiring additional anesthesia and contrast. This increases the risk of kidney damage, embolism, or tissue injury. Prolonged surgery due to these issues may also lead to heart attacks or death.
Patients undergoing cardiac procedures who use the recalled iCast stent systems are at risk. Medical professionals performing the procedures with these stents may face complications.
Check the product code on the stent packaging. The recalled items have specific codes ranging from 85400 to 85455. These stents are used in cardiac procedures and sold with specific lengths and sizes.
Your doctor will determine if the recalled stent system was used in your procedure and may recommend alternatives.
The recall is due to increased customer complaints about stent separation during delivery, which can cause procedural delays, additional anesthesia, and potential kidney damage.
The recalled stents have product codes from 85400 to 85455, including specific sizes and lengths.
The recall does not provide a fix; the remedy is null, so users must contact their doctor for alternatives.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1077-2022 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-1077-2022 from Atrium Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
