The US Food and Drug Administration (FDA) has classified Teleflex’s recall of Arrow FiberOptix Intra-Aortic Balloon (IAB) Catheter Kit and Arrow UltraFlex IAB Catheter Kit as Class I, the most serious recall.
Arrow FiberOptix IAB Catheter Kit and Arrow UltraFlex IAB Catheter Kit are designed for use with a balloon pump and jointly used on patients undertaking cardiac and non-cardiac surgery.
Both catheter kits are also used for the treatment of adults who have acute coronary syndrome or complications of heart failure.
Teleflex, and its subsidiary Arrow International, are recalling both products over a manufacturing glitch that could result in the catheter’s balloon being overtwisted.
According to FDA, the error can sometimes be identified visually but the device could still be affected even if the problem isn’t visually detectable.
The error may inhibit the balloon from fully inflating, causing blood to accumulate in the tubing, helium leakage, potential damage to the catheter, or difficulty during insertion.
The health agency highlighted that the use of both kits can result in serious injury, including blood loss, tear in the artery, unstable blood pressure, prevention of blood flow to the heart, or death.
As of now, Teleflex and Arrow International have received 322 complaints. This includes 31 injuries and three deaths that are potentially related to this issue.
FDA said people receiving circulatory support using the Arrow FiberOptix IAB Catheter Kit or Arrow UltraFlex IAB Catheter Kits can be affected.
In addition, healthcare workers who are providing care using the device can also be impacted.
In total, Teleflex/Arrow International has recalled 16,959 devices with certain product codes, distributed between 7 May 2022 to 8 April 2024. The recall was started on 29 April 2024.
Furthermore, the medical device company issued an Urgent Medical Device Notification letter to customers, healthcare workers, medical facilities, and distributors.
The letter included recommended actions for the use of the catheter kits and how to report to the company in case of defective products.
Recently, the health regulator identified Medtronic’s recall of StealthStation S8 applications as the most serious recall.
