Dive Brief:
- Teleflex has recalled catheter kits linked to reports of 31 injuries and three deaths, the Food and Drug Administration said Thursday.
- The company advised customers to take precautions in April after learning that a manufacturing error may cause the catheter’s balloon to become overtwisted.
- Teleflex reported 322 complaints about the problem, which may prevent the balloon from fully inflating and cause other issues that could lead to serious injury or death.
Dive Insight:
The recall affects nearly 17,000 intra-aortic balloon catheter kits that Teleflex and its subsidiary Arrow International distributed in the U.S. between May 2022 and April 2024. Physicians use the devices with balloon pumps during cardiac and non-cardiac surgery, as well as to treat acute coronary syndrome or complications of heart failure.
Overtwisted devices can cause blood to backup in the tubing, allow helium to leak, and lead to catheter damage or insertion difficulty during use, the FDA said. Potential complications include blood loss, tears in the artery, unstable blood pressure and prevention of blood flow to the heart.
The complications can cause serious injury or death, leading the FDA to categorize the action as a Class I recall.
Healthcare professionals can continue to use affected devices. Teleflex has advised users to check devices for signs of overtwisting and not use products they suspect have the fault. However, the issue is not always visible and Teleflex wants users to ensure a back-up intra-aortic balloon catheter is available.
Teleflex also said healthcare professionals must use fluoroscopy to assess the completeness of balloon inflation and respond to any alarms from the pump. Certain alarms require the immediate attention of a healthcare professional.
The notice is the latest in a series of recalls of products sold by Arrow, which Teleflex acquired in a $2 billion deal in 2007. In February, Teleflex recalled more than 330,000 catheterization kits over a fault linked to 10 injuries and one death. The company also took other actions in response to “mislabeling regarding the presence of chlorhexidine” and complaints about separations and leakage.
Teleflex CEO Liam Kelly discussed the latest catheter recall on an earnings call in May, telling investors that the company expected “the financial impact from the voluntary field action to be immaterial.”