FDA Recalls PTCA Scoring Balloon Catheters

Emma Hitt, PhD

Disclosures

September 10, 2010

September 10, 2010 — The AngioSculpt percutaneous transluminal coronary angioplasty (PTCA) scoring balloon catheter (AngioScore Inc), used to dilate narrowed coronary arteries and improve myocardial perfusion, is subject to a US Food and Drug Administration (FDA) class 1 recall.

The recall applies to only to the "EX" catheters, with all part/REF numbers 2034-XXYY with lot numbers less than F09060003. The product was distributed from January 30, 2009, through December 4, 2009.

According to the manufacturer, the PTCA catheters may become separated during use, and fragments of the catheter may become lodged in coronary arteries and could result in serious injury or death.

The manufacturer called for customers to inspect the device on December 4, 2009, and to note any product that appeared to be affected. The FDA announced the reclassification to a class 1 recall this week.

According to the FDA, class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

More information about this recall is available on the FDA's Web site.

Also announced this week, the FDA is reclassifying standard PTCA catheters from class 3 (premarket approval) into class 2 (special controls), although cutting/scoring PTCA catheters remain in class 3 and continue to require premarket approval applications. A guidance document for the class 2 special control is available on the FDA'S Web site.

Adverse events related to PTCA catheters should be communicated to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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