- Getinge’s Atrium Medical is recalling 68,812 iCast Covered Stent System devices from the U.S. because of an issue linked to 75 complaints and nine injuries.
- The recall, which the Food and Drug Administration categorized as a Class I event, relates to the separation of the balloon or catheter hub during the removal of the delivery system from the patient. Separation can extend the duration of the procedure and lead to blood vessel blockages that result in amputation.
- In light of those risks, Atrium is asking users to take certain precautions when using the devices, for example by fully deflating the balloon before withdrawal and stopping if resistance is felt.
Getinge struck a $680 million deal to buy Atrium in 2011, giving it control of a business it considered to be the No. 2 player in the global covered stents market. The iCast product covered by the recall is used to hold open airways, while its indicated use is as a treatment of tracheobronchial strictures caused by malignant neoplasms. The device received premarket approval from the FDA in 2005.
Since then, iCast has been used in more than 500,000 patients, mostly without incident. The device was subject to one recall prior to the latest event, a Class II recall that Getinge initiated in 2017 after learning it had printed the wrong dimensions on the catheter hub. That recall affected 183 units in the U.S.
In the latest recall, the FDA said the balloon or catheter hub is most likely to split from the delivery system during removal if the device is being used off-label such as in the treatment of vascular conditions. A 2020 systematic review of covered balloon-expandable stents found iCast “is commonly used” to treat the vascular condition aortoiliac occlusive disease.
When used in a vascular context, the balloon can separate if removal from the blood vessel is attempted before it is fully deflated, the agency said. Separation can cause a range of complications. If balloon separation causes the procedure to take longer than expected, the patient may be exposed to additional anesthesia or contrast imaging agents, according to the FDA.
Separation can also lead to vascular occlusion, the blocking of a blood vessel. Depending on the location of the blockage, outcomes can include amputation, embolism, loss of organ function, organ infarction and tissue death. The regulator said there have been 75 complaints and nine injuries related to the issue. No deaths have been reported.
Atrium alerted users to the issue in March. The notice provided physicians with advice on the deflation and withdrawal of the device. The instructions are intended to ensure physicians fully deflate balloons before withdrawal and do not force the withdrawal of the delivery system if they encounter resistance.