Atrium Medical recalls specific stent models due to increased risk of balloon or catheter hub separation during delivery, potentially causing procedural delays, additional anesthesia, and kidney damage. Affected products include 85320-85398 series.
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 certain covered stent systems used in medical procedures because they can separate during delivery, causing delays and potential kidney damage. This risk may lead to serious complications like organ damage or amputation.
During stent delivery, the balloon or catheter hub may separate from the delivery catheter. This can cause procedural delays, require additional anesthesia and contrast, and increase the risk of kidney damage. In severe cases, it may lead to organ damage, amputation, or death.
Healthcare professionals using the Atrium Advanta V12 stent systems for procedures are most at risk. Patients undergoing procedures with these stents could face complications if separation occurs.
Check for product codes 85320 through 85398 in the list provided by Atrium Medical. These stents are used in medical procedures and are only available for OUS (Outpatient Surgical) settings.
Review the product codes listed (85320-85398) to confirm if your stent system is affected.
Atrium Medical observed increased customer complaints about stent separation during delivery, which can cause procedural delays, additional anesthesia, and potential kidney damage.
Separation during delivery may lead to complications like organ damage, amputation, or death due to prolonged surgery and increased surgical stress.
Check if your stent has a product code from 85320 to 85398 as listed by Atrium Medical.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1076-2022 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-1076-2022 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.
