Medtronic’s Catheter Manufacturing Practices Under Fire After FDA Cites Quality Issues
WASHINGTON, DC – According the U.S. Food and Drug Administration Medtronic Rashkind Balloon Septostomy Catheters recall raises concerns about the quality manufacturing practices of Medtronic. Especially since many of Medtronic’s catheters have been recalled due to the outer coating breaking from the device, which may leave behind fragments in patients after the device is removed.
Both the fragments of coating that can be left in the patient, and the attempts to remove those fragments can lead to a person developing blocked blood vessels, damage to their blood vessel walls, blood clots, heart attacks, and embolisms. In some instances, death could result from the injuries. So far, the catheters have caused five complaints of injuries.
The recall is being classified as a Class I by the FDA. Class I recalls are only used for the most severe defects in situations where the use of the device creates a chance of serious harm or death.
Medical devices and medications are complex types of products that can cause serious problems if they fail to function exactly as intended. When a person sustains injuries because of a defective medical product, the injured person can collect compensation from the company that made the product.
In some instances, these recalls can create serious challenges for patients and medical practitioners. For instance, some medical devices are implanted in patients. A recalled implant device cannot just be returned, but would have to be surgically removed. In other situations, a lifesaving medication could be contaminated, causing risks to a patient who takes the medication but also risks to the patient for ceasing the medication. Because of how high the stakes are when it comes to medical products, manufacturers of these products must be cautious and ensure the devices have been tested extensively.
Medtronic’s Rashkind Balloon Septostomy Catheters are utilized in surgical procedures to enlarge an already existing atrial septal defect in the patient or to create a new atrial septal defect as part of a treatment option for patients with Cyanotic Congenital heart defects.
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