FDA categorizes Cordis catheter recall linked to 8 injuries as Class I event

Dive Brief:

FDA has categorized Cordis’ recall of its vascular visualization catheter as a Class I event after learning of eight injuries linked to the fault.
Cordis has advised physicians against using the affected devices in procedures in which they may become trapped between endovascular devices and the vessel wall. When trapped, the catheter can stretch during removal and cause marker bands to move or dislodge.
The Class I recall comes a decade after Cordis flagged up the potential for marker bands to dislodge into the vascular system when the catheter is stretched. Cordis, which was then owned by Johnson & Johnson, was recently sold by Cardinal Health to a private equity firm.

Dive Insight:

Cordis includes radiopaque marker bands on its Super Torque MB Angiographic Catheter to provide easy location information and support the measurement of the vasculature. However, the feature has caused problems. In 2011, Cordis shared details of a procedure in which the bands came off in the patient’s vasculature. An additional stent placement was needed to trap the bands. FDA issued a Class II recall alert in relation to the notice from Cordis.

The new Class I notice only applies to devices distributed from the start of 2019 to July 20, 2021 and relates specifically to the risk of marker bands becoming dislodged when the catheter is trapped. As the surgeon attempts to remove the trapped catheter, the device can stretch to the extent that the marker bands move. FDA has heard of 167 complaints, 8 injuries and no deaths linked to the issue.

Dislodged marker bands could delay procedures, damage the vasculature, require additional surgery, and lead to heart attacks, strokes or blockages of blood vessels in the lungs. Given the dangers, FDA put the recall in its highest risk category.

Cordis has advised physicians not to use the device in procedures in which the catheter could be trapped. The company also reminded physicians of instructions for use that warn about stretching the catheter. Cordis has concluded the events are not related to a manufacturing defect. The recall follows Class I and II recalls for other Cordis products earlier in the year.

The recalls are part of a broader set of issues that have dogged Cordis since its takeover by Cardinal Health. Earlier this year, Cardinal gave up on trying to make the acquisition work, choosing instead to sell Cordis to private equity firm Hellman & Friedman for around $900 million less than it paid to buy the business in 2015. Hellman & Friedman closed the takeover last month.