AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018″ Platform Recalled due to Design Defect

Risk Managers and Cardiology healthcare personnel are informed by the FDA that AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018″ Platform is recalled because of design defect which can lead to serious injury or death.

Background of AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018″ Platform

The AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018″ Platform, by AngioScore Inc., is used for dilatation of lesions in the infra popliteal, popliteal, ilia-femoral, femoral, iliac and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

FDA Alert on AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018″ Platform

FDA’s reason for the recall is that AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018″ Platform because of a design defect the device fragments may cause significant arterial injury leading to surgical intervention or death.

The affected model part (REF) numbers are:

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

including all lot codes and sizes.

This recall covers 17,682 units with distribution dates from 09/2007 to 11/2010.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

Recommendation on AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018″ Platform

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

Contacting the FDA to report cases with AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018″ Platform

In case of detection of adverse events or side effects related to the use of AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018″ Platform, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

AttorneyOne.com is a free nationwide legal referral service. We are not a law firm. We help consumers find the best representation for their legal needs.