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Merit Prelude Short Sheath Catheter Introducer: Class I Recall - Tip May Detach During Use

Sun, 02/13/2011 - 2:25pm
FDA MedWatch

AUDIENCE: Cardiology, Nephrology, Risk Manager

ISSUE: Introducer tip may detach during use, causing arterial injury, hemorrhaging, or other serious events, while introducer tip material may enter into the bloodstream, causing blood clots (thrombosis).

BACKGROUND: The Merit Prelude Short Sheath Catheter Introducer is used to provide access and facilitate the introduction of other medical devices into veins or arteries while maintaining hemostasis for a variety of procedures.

RECOMMENDATION: Merit Medical Systems, Inc. is advising customers to immediately discontinue use of any affected product, examine their inventory, and quarantine all affected product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[02/04/2011 - Recall Notice - FDA]

    

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