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Teleflex/Arrow International Recall Arrow FiberOptix and UltraFlex Intra-Aortic Balloon (IAB) Catheter Kits for Manufacturing Issue That May Prevent Full Balloon Inflation and Cause Patient Harm
Teleflex, and their 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. 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.
The FDA has identified this as a Class I recall, the most serious type of recall. Please be aware, this recall is a correction, not a product removal. Use of these devices without correction may cause serious injuries, serious health consequences, or death.
Questions?
Customers with questions should contact Teleflex and Arrow International Customer Service at 1-866-396-2111 or Recalls@teleflex.com.
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