Short Sheath Catheter Recall

Merit Medical Systems has issued a recall for 378 Prelude Short Sheath catheters. The concern is that the tip of the Catheter may break off and enter the bloodstream. The FDA categorizes this as a Class I medical device recall, which is the most serious device recall the FDA can issue. While there are no reports of injuries, the FDA is concerned this problem could lead to serious injury or death. However, there have been no injuries reported in connection with Prelude catheter tips breaking off.