A Class-I recall was recently announced by the U.S. Food and Drug Administration pertaining to the ev3 NanoCross .014" PTA Dilation Catheter, which has been reported to have the potential to crack or break.
The Class I recall, which is the most serious type of recall of products believed to pose a serious health consequence, was issued for the catheter because it has shown a potential for cracking or breaking. Should that happen, it could cause potential embolization of catheter fragments, leading to surgery, injury, bleeding, and possible death.
Reports say the Catheter is intended to allow infirm patients to continue basic bodily functions while hospitalized or otherwise incapacitated. Once the patient is well enough to stand and move to the bathroom, it is removed and discarded. But in mid-November, the NanoCross .014" OTW PTA Dilatation Catheters were voluntarily recalled, and a request was issued that all affected products be located and removed from use.
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