Teleflex/Arrow International have recalled the Arrow FiberOptix and UltraFlex Intra-Aortic Balloon (AB) Catheter Kits due to a manufacturing issue that could prevent the balloon from inflating fully, potentially causing harm to the patient. The FDA has the release.
The kits are used together with a balloon pump in “patients undergoing cardiac and non-cardiac surgery, and to treat adult patients who have acute coronary syndrome or complications of heart failure.” The reason for the recall is that the catheter’s balloon can become “overtwisted,” an issue that can sometimes be detected visually but not always. Use of the device could 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.” In total, Teleflex/Arrow International has received 322 complaints that include 31 injuries and 3 deaths that potentially arose from the issue.
The company recommends that healthcare professionals “ensure that a back-up intra-aortic balloon catheter is available before using this device” and “inspect all intra-aortic balloon catheters in the scope of this recall for signs of an over-twisted balloon wrap or bent balloon shaft before use,” among other instructions. The catheter should be replaced if the issue is identified or suspected, and it should be reported to Teleflex.
