The Food and Drug Administration (FDA) announced today the recall of a defective medical device used to “dilatate,” or enlarge, arterial lesions during certain surgeries. The product’s manufacturer, AngioScore, Inc., issued the recall after discovering a design defect that may lead to peeling of the bond and/or detachment of part of the instrument. These events could potentially lead to serious arterial injury causing death, or necessitate further surgery.
The AngioScore recall, which affects more than 17,000 units, involves the Angiosculpt Percutaneous Transluminal Angioplasty Scoring Balloon Catheter; OTW 0.018 Platform (multiple sizes), lot codes 2076-4020, 2076-5020, 2076-6020, 2092-6020 and 2105-6020. These devices are 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,” according to the recall notice. AngioScore has advised its customers to immediately suspend use of the instruments, check their inventory and quarantine all affected units.
Class I recalls are the most serious recall issued by the FDA. This type of recall is reserved for medical devices and drugs that pose an immediate risk of injury or death to patients. Any harm caused by a defective drug or medical device may be grounds for a personal injury lawsuit. An adverse medical event or death caused by a defective product may also be grounds for a defective product wrongful death lawsuit.
For more information on defective medical device lawsuits, contact a personal injury lawyer or visit YourLegalGuide.com’s section focusing on this subject.