Millar Mikro-Tip Catheter Recall: Risk of Embolism
The potential presence of particulate debris, which could get into the bloodstream and cause patients to suffer an embolism, has led to a recall of some models of the Mikro-Tip Angiographic Catheter by Millar Instruments, Inc.
The Mikro-Tip catheter recall was announced on March 21 by the FDA after an investigation determined that there was debris in the catheter lumen of some models. The debris could get into the body, blood and tissues and cause damage to organs, resulting in stroke, heart attack, limb ischemia or death.
The risk of debris getting into the body is increased due to a high speed injection feature. Although there have been no injuries or illnesses reported in connection to the catheter recall, the FDA is likely to classify the market withdrawal as a Class 1 recall. 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.
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The recall affects about 1,080 Mikro-Tip Human Use High Injection Angiographic Catheters with model numbers SPC-454D and SPC-454F with expiration dates beyond March 2011. The catheters were distributed internationally and in California, the District of Columbia, Massachusetts, Michigan, Minnesota, New York and Pennsylvania.
Millar says it has notified all customers and distributers by e-mail and phone to warn them of the recall and to make arrangements for the return of the affected products. Customers with questions can call Millar Instruments at 1-800-669-2343.
Doctors and patients who experience adverse reactions from the use of the recalled catheters should call the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch.
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