Teleflex recalls catheter kits due to overtwisting risk

Teleflex and its subsidiary Arrow International are recalling the Arrow FiberOptix Intra-Aortic Balloon Catheter Kit and Arrow UltraFlex Intra-Aortic Balloon Catheter Kits after finding that a manufacturing error may cause the catheter’s balloon to become overtwisted. The issue can sometimes be identified visually, but a device may still be impacted even if the issue cannot be detected visually and all mitigations outlined in this recall should be followed. This issue may: 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. Use of this device may cause serious injury, including blood loss, tearing in the artery, unstable blood pressure, prevention of blood flow to the heart, or death. Teleflex/Arrow International reports 322 complaints. A total of 31 injuries and 3 deaths have been reported potentially related to this issue. The company said 16,959 of such devices are being recalled in the U.S.