Teleflex catheter kit recall associated with 31 injuries, 3 deaths

Teleflex has recalled nearly 17,000 intra-aortic balloon catheter kits distributed in the U.S. between May 2022 and April 2024 due to concerns over a manufacturing error. The recall follows reports to the FDA of 31 injuries and three deaths linked to the catheter's balloon becoming overtwisted.

The issue can prevent the balloon from fully inflating during use, potentially leading to complications such as blood backup in tubing, helium leakage, and difficulties in catheter insertion. Serious outcomes include blood loss, artery tears, unstable blood pressure, and compromised blood flow to the heart.

Despite the recall, healthcare providers are advised to continue using the affected devices while carefully checking for signs of overtwisting. Teleflex recommends having backup catheters on hand and using fluoroscopy to ensure proper balloon inflation, responding promptly to pump alarms signaling potential issues.

This action marks another significant recall for Teleflex, which previously recalled catheterization kits and addressed issues related to mislabeling and leakage complaints.