The FDA today determined that Atrium Medical’s recall of some of its iCast covered stents is Class I, the most serious kind.
Hudson, N.H.–based Atrium Medical — a subsidiary of Swedish medtech giant Getinge — is recalling certain iCast covered stent systems due to complaints of separation of the balloon or catheter hub from the delivery system when the delivery system is being removed from a patient. There are 68,812 devices involved in the recall, including all lots distributed between December 31, 2018 to March 31, 2022.
Atrium Medical reports that there have been 75 complaints, nine injuries and no deaths related to the device.
The company said in an FDA warning letter that the issue occurs most often when the stent system is used outside of the indications for use. If a separation occurs and the balloon does not fully deflate before being removed from a blood vessel, it could extend the procedure time. The separated portion also has the potential to remain in the body after the delivery catheter is removed which could lead to vascular occlusion.
Healthcare professionals who use iCast to treat vascular conditions and people who have catheter-based vascular procedures using iCast are likely to be affected by the recalls, according to the FDA notice. Atrium Medical issued an urgent medical device correction letter in March to all customers in which it instructed users to read the new deflation and withdrawal instructions prior to using the device.
