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U.S. Department of Health and Human Services

Safety

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Mikro-Tip Angiographic Catheter, Model SPC-454D and SPC-454F by Millar Instruments Inc.: Class 1 Recall

[Posted 04/01/2011]

AUDIENCE: Risk Manager, Radiology, Cardiology

ISSUE: Millar Instruments, Inc, and FDA issued a recall of Human Use High Injection Angiographic Catheter, Models SPC-454D and SPC-454F. There is a possibility that small particles (debris) may be found inside the catheter. This foreign debris can potentially travel (embolize) from the catheter to tissues, blood vessels, limbs and organs. This could lead to a decreased blood supply to these structures which can result in serious injury and /or death.

BACKGROUND: This device measures pressure within the blood vessels. It is capable of delivering high-speed injection of material that is not absorbed into the body (radiopaque contrast media). This material is then used to view blood vessels. A total of 965 Catheters of SPC-454D and 454F were distributed to Millar international distributors and 115 catheters were distributed to Millar customers in 7 states. These states are California, District of Columbia, Massachusetts, Michigan, Minnesota, New York, and Pennsylvania.

RECOMMENDATION: Customers can arrange for return of all recalled products. Questions may be directed to the Millar Instruments at 1-800-669-2343. 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


[03/31/2011 - Recall Notice - FDA]

[03/21/2011 - Firm Press Release - Millar Instruments, Inc]