The FDA determined this week that Cordis’ recent recall of several versions of its Super Torque angiographic catheters meet the criteria of a Class I recall, a label reserved for those the agency believes carry the highest risk of serious injury or death.
Angiographic catheters are inserted into arteries to examine the inside of the blood vessel for evidence of aneurysm, pulmonary embolism, plaque build-up, aortic dissection and more. They can also be used to assess the scope of already-diagnosed conditions like coronary artery disease, stenosis and congenital heart disease.
Some of Cordis’ angiographic catheters are lined with evenly spaced gold-alloy marker bands visible via X-ray, helping physicians monitor catheter placement and perform measurements throughout an angiogram procedure.
Those bands are the cause of the recall because they could come loose during certain procedures and either move out of their designated positions or, at worst, escape the catheter completely.
A total of 25,000 devices distributed between January 2019 and July 20 of this year are covered by the recall.
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Cordis started the recall in May. In an alert sent to customers in late July, the company explained that when the catheters are used in procedures that place them between blood vessel walls and endovascular devices, the resulting friction can stretch out the catheters and displace the marker bands.
That movement up or down the catheter could ruin physicians’ measurements throughout the angiogram, causing mistakes in their diagnoses and device sizing. Meanwhile, if the bands are dislodged from the catheter and left inside the blood vessel, they could cause blood clots, potentially leading to heart attack or stroke and the need for further invasive procedures.
As of the FDA’s recall notice this week, 167 complaints had been reported. The problem has so far been linked to eight injuries and no deaths.
Because the problem isn't linked to a manufacturing defect but to misuse of the catheters, Cordis is not requesting that the devices be returned. Instead, healthcare providers are advised not to use the Super Torque catheters with marker bands in situations that would wedge them between vessel walls and other devices. Cordis also said that the catheters should only be inserted or removed with the help of a guidewire and that physicians should proceed with extreme caution if they feel any tension or resistance while using the devices.
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Cordis’ recall came amid its $1 billion sale to private equity firm Hellman & Friedman from Cardinal Health, which in turn had purchased the devicemaker from Johnson & Johnson for $1.9 billion in 2015. Cardinal laid out its plans to sell off Cordis in March, and the deal was completed last month.
Cardinal, too, has faced down the Class I recall label in recent months. In August, just weeks apart, the FDA attached the label to two of Cardinal’s recalls. One stemmed from a locking mechanism on a scalpel used in umbilical venous catheter procedures, which had been linked to two patient deaths, while the other addressed a flaw in some of its prefilled saline syringes that could cause excess air to be injected into blood vessels.