Merit Prelude Catheter Recall: Tips May Break Off
Nearly 400 Merit Medical Systems Prelude catheters have been recalled due to the risk of the tip breaking off and entering the bloodstream.
The FDA announced the Merit catheter recall this week, saying that the agency considered it to be a Class I medical device recall. The recall was issued after it was determined that the introducer tips on the Prelude Short Sheath Catheter Introducers could detach during use. The tips could enter patients’ bodies and cause arterial injury, hemorrhaging and other injuries, and the materials in the tip could cause blood clots.
A Class I recall is the most serious category of medical device market withdrawal and means that the FDA believes there is a reasonable probability that use of the device will cause serious injury or death. However, there have been no injuries reported in connection with Prelude catheter tips breaking off.
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The catheter recall affects 378 units of the Prelude Short Sheath Introducer, 7F-SMT, 4cm. The catheters have a reference number of PSS-7F-4-038MT and a lot/serial number of H179757. It is a catheter that is used to introduce other medical devices into veins or arteries.
The company originally warned sales representatives and distributors about the problems on December 17, 2010, telling them to immediately contact customers and identify, quarantine and return all of the unused catheters affected by the recall. Distributors were also told to issue the warning to any customers that may have received the catheters. Once the FDA became aware of the warning it determined that the action constituted a Class I recall.
Customers with questions can contact Merit Medical Systems, Inc. at 1-801-316-4932 or 1-800-356-3748.
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