Teleflex and its subsidiary Arrow International have received 322 complaints and reports of 31 injuries and three deaths related to nearly 17,000 intra-aortic balloon pumps, the FDA said June 13.
The Arrow FiberOptix Intra-Aortic Balloon Catheter Kit and Arrow UltraFlex Intra-Aortic Balloon Catheter Kit are used with patients undergoing surgery and to treat adult patients who have acute coronary syndrome or heart failure. In late April, the company told customers about a manufacturing error that could cause the balloons to become overtwisted.
The issue could "prevent the balloon from fully inflating, cause blood to back up in the tubing, allow helium to leak, and lead to catheter damage or insertion difficulty during use," according to the FDA.
The devices are not being removed from the market, but the FDA classified the warning as a Class I recall because of the health risks, which include blood loss, tearing in the artery, unstable blood pressure, myocardial ischemia or death.
Teleflex and Arrow International instructed customers to stock a back-up device in case a replacement is needed, be vigilant in responding to pump alarms and bedside indicators of an issue, and inspect all affected products for an over-twisted balloon wrap or bent balloon shaft.