FDA Says Teleflex/Arrow International Recall Arrow FiberOptix And UltraFLEX Intra-Aortic Balloon Catheter Kits For Manufacturing Issue As Class I Recall; Total Of 31 Injuries & 3 Deaths Have Been Reported Potentially Related To Manufacturing Issue
Portfolio Pulse from Benzinga Newsdesk
The FDA has classified the recall of Teleflex/Arrow International's Arrow FiberOptix and UltraFLEX Intra-Aortic Balloon Catheter Kits as a Class I recall due to a manufacturing issue. This issue has been potentially linked to 31 injuries and 3 deaths.
June 13, 2024 | 7:46 pm
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Teleflex's recall of Arrow FiberOptix and UltraFLEX Intra-Aortic Balloon Catheter Kits has been classified as a Class I recall by the FDA due to a manufacturing issue. This issue has been linked to 31 injuries and 3 deaths, which could negatively impact the company's stock in the short term.
The classification of the recall as Class I by the FDA indicates a serious risk to health, which is likely to negatively impact investor sentiment and Teleflex's stock price in the short term. The reported injuries and deaths further exacerbate the situation.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100