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Class I Recall Issued for AngioSculpt PTA Scoring Balloon Catheter

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A design defect that can result in serious arterial injuries, some of which could be fatal, has prompted AngioScore Inc. to recall its AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018″ Platform. The device is used for dilatation of lesions in the iliac, femoral, ilia-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018″ Platform was recalled because of a design defect causing unintended fracture and peeling, and has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. According to the recall notice, use of affected devices may lead to retained device fragments or significant arterial injury. This can lead to death or the need for additional surgical intervention.

The US Food & Drug Administration (FDA) has deemed this recall a Class I recall. This is the agency’s most serious type of recall, and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

This recall affects 17,682 units distributed from 09/2007 to 11/2010. It includes the following model part (REF) numbers and includes all sizes and lot codes for each model listed:

• 2076-4020
• 2076-5020
• 2076-6020
• 2092-6020
• 2105-6020

AngioScore is advising customers to immediately discontinue use of any affected product, examine their inventory, and quarantine all affected product.

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