Two intra-aortic balloon catheter kits recalled; three deaths reported
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Key takeaways:
- The recall of two varieties of intra-aortic balloon catheter kits has been designated as class I by the FDA.
- A manufacturing error causing balloon overtwisting potentially resulted in three deaths, the FDA said.
Teleflex and its subsidiary Arrow International issued a recall of its intra-aortic balloon catheter kits due to a manufacturing error that may cause the balloon to become overtwisted.
The FDA has identified this as a Class I recall, the most serious type of recall, as use of these devices (FiberOptix and UltraFlex, Arrow) may cause serious injury or death. Of note, this recall is a correction, not a product removal.
If the intra-aortic balloon becomes overtwisted, it may cause blood loss, artery perforation, hemodynamic instability, myocardial ischemia or death, according to an alert from the FDA.
Although overtwisting can sometimes be identified visually, a device may still be impacted, according to the alert.
The recall includes 16,959 devices distributed between May 7, 2022 and April 8, 2024.
There have been 322 complaints, 31 injuries and three deaths potentially related to this issue, according to the FDA alert.
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