FDA Issues Class I Recall of AngioScore Catheters
The Food and Drug Administration has indicated the possibility of significant medical devices liability when it recently issued a recall of 17,682 angioplasty balloon catheters manufactured by AngioScore Inc. due to their defective design. The catheters were recalled because of the possibility of the devices fracturing and peeling, which could lead to fragments being left inside a body, injuries to arteries, additional surgeries and even death.
The recall was initiated in December 2009 but was recently expanded and reissued. The recall has been classified as a Class I medical device recall, which means that the FDA has deemed it reasonably possible that the device will cause serious injury or death. However, no severe injuries or deaths have yet been reported.
The catheters are used to dilate lesions in arteries and to treat obstructive lesions of native or synthetic arteriovenous fistula.
The recall includes all model numbers of the AngioSculpt PTA Scoring Balloon Catheter OTW 0.018" Platform. The product was distributed from September 2007 to November 2010. The recall does not include the AngioSculpt PTCA catheters or any of the AngioSculpt PTA catheters in sizes other than OTW 0.018" Platform.
AngioScore has voluntarily recalled the product and has notified their customers through the mail. The company is advising hospitals and consumers to immediately stop using the catheters and to examine their inventory for any potential defects.
The FDA is urging healthcare providers and patients to report any defects or side effects involving the catheters to their MedWatch Safety Information and Adverse Event Reporting Program.
If you or a loved one has suffered injuries due to AngioScore catheters, contact an experienced product liability attorney to discuss your case.