Teleflex recalled its Arrow FiberOptix IAB catheter kit and Arrow UltraFlex IAB catheter kit. This recall is a correction, not a product removal. However, the issues related to the kits resulted in reports of 31 injuries and three deaths, the FDA said in a notice.
Arrow IABs work with a balloon pump for patients undergoing cardiac and non-cardiac surgery. They also treat adult patients who have acute coronary syndrome or complications of heart failure. According to the FDA, Teleflex recalled these specific pumps after finding a manufacturing error that may cause the balloon to become overtwisted.
Users can sometimes identify overtwisting visually, but the issue could affect a device even if the user fails to see it. The issue may prevent the balloon from fully inflating, cause blood to back up in the tubing and allow helium to leak. This may lead to catheter damage or insertion difficulty during use.
The issue may cause serious injury, including blood loss, tearing in the artery (perforation), unstable blood pressure (hemodynamic instability), prevention of blood flow to the heart (myocardial ischemia), or death. Teleflex received 322 complaints that included the 31 injuries and three deaths related to the issue.
Teleflex initiated the recall on April 29, 2024, recalling 16,959 devices distributed in the U.S. between May 7, 2022, and April 8, 2024.
Recommendations to Teleflex customers regarding this recall
In an urgent medical device notification, Teleflex instructed customers to ensure the availability of a back-up IAB catheter before using the device. They should also inspect all IAB catheters for signs of overtwisted balloon wraps or bent balloon shafts.
Additionally, customers should use fluoroscopic guidance to insert all IAB catheters in the scope of the recall. They must use fluoroscopy to assess the completeness of balloon inflation, once inserted and connected.
Teleflex also advised vigilance in responding to pump alarms and bedside indicators that could mean unexpected performance. That could include blood in the helium pathway and lower-than-expected diastolic pressure augmentation.
If customers identify the issue, they should remove the catheter and replace it as outlined in the instructions for use. They may insert a replacement contralaterally or ipsilaterally after considering individual femoral access options and relevant clinical features. Customers should also report every suspected incidence of the condition to Teleflex as soon as practical.
