iCast Covered Stent Recall Issued Over Separation Risks
Nearly 80,000 stent systems used to hold open patient airways have been recalled, following dozens of reports involving problems with the components separating during removal, which poses a serious injury risk for patients.
The FDA announced the iCast Covered Stent recall on June 2, warning healthcare professionals to carefully review updated removal instructions to prevent accidental separation of the components.
As of June 2, the manufacturer indicates there have been at least 75 complaints involving problems with the iCast Covered Stent, including nine injuries which occurred when the balloon or catheter hub separated from the stent during removal.
The recall impacts approximately 68,812 devices, which were manufactured by Atrium Medical Corporation, and distributed to healthcare facilities nationwide from December 31, 2018 through March 31, 2022.
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The iCast system is a balloon expandable stent, which can be delivered using a catheter to hold open the airways and support the walls of the structures within the body. However, the recall notice indicates that there have been an increasing number of complaints involving the separation of the balloon or catheter from the iCast stent while the delivery system is being removed from patients. Officials warn the stent separations have occurred most frequently when the iCast devices are being used to treat vascular conditions, which is outside of the indications for use.
Healthcare providers are being warned that, in the event the components of the stent delivery systems separate during removal, patients could be at an increased risk of suffering prolonged surgical procedures and require additional anesthesia.
In severe cases, a separated portion of the iCast system could remain in a patient’s body after the delivery system has been removed, increasing the risk of vascular occlusion which could cause amputation, embolism, loss of organ function, organ infarction, and tissue infarction.
Atrium Medical Corporation issued an Urgent Medical Device Correction letter on March 3, 2022, instructing users to deflate the balloon and allow sufficient time for full deflation. Healthcare professionals should verify full deflation of the balloon via fluoroscopy before attempting to withdraw the delivery system and to not force withdrawal of the delivery system if resistance is encountered. The FDA has categorized the iCast stent recall as a Class I recall, which is the most serious of its kind, and suggests that continued use of the recalled product could result in serious injuries, and even death.
Customers and patients are being encouraged to report any adverse events or injuries arising from the use of the iCast Covered Stent systems by reporting the incidents to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Customers with additional questions or concerns regarding the iCast Covered Stent recall are being asked to contact Atrium Medical Corporation at 603-880-1433.
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