A Class I recall is the most serious type of recall, typically announcing the risk of a life threatening illness due to a defect in a product. Cardiologists and Risk Managers recently received notice that components in the Arstasis One Access System may fracture and/or separate which could result in an emergent life threatening situation.
The Arstasis One Access System is used to support a diagnostic test during upper leg catheterization procedures. The device supports the diagnostic test by providing access to the vascular system so the cardiologist can identify abnormalities in the vascular system. The Arstasis One Access System also offers a means to help halt bleeding from the upper leg artery that is being tested. Cardiologists and Risk Managers will be reporting any emergent situations, health issues or side effects that relate to the malfunction of the component sin the Arstasis One Access System to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
The Arstasis One Access Systems involved in this recall include: Models: AAD100, AAD101; Part Numbers: FG-02279, FG-03010; Lot Numbers: 09I10268, 1OC26337, 09J06281, 10C12334. These products were distributed for five months beginning May 14, 2010.
Cardiologists are not liable for defective products that cause harm to patients. Of course, all physicians take precautions by examining technology before use. However, physicians are not engineers and cannot be responsible for identifying defects in products. By the same token, sometimes physicians do discover defects, either by viewing an abnormality in the product or seeing a patient with an unusually expected complication following use of the product.
Medical device manufacturers are responsible and can be held liable for any defective product that causes serious injury or death to an individual. So, there are lawyers who specifically handle cases involving defective medical devices.
If you, your family or a friend have suffered serious inury and need assistance in asserting your legal rights for compensation, contact PADOVE LAW, toll free at (877) 446 5294 for a free consultation.