More Than 106,000 Defective Catheters Recalled
The U.S. Food and Drug Administration announced a Class I recall, the most critical version of a recall that indicates that using the specified product can lead to serious injuries or fatalities, for more than 106,000 catheters manufactured by medical device company Medtronic.
Reason for Recall
The manufacturer issued the recall after it received five or more customer complaints regarding the product. Customers reported that the catheters broke while they were being used but they did not report any serious injuries or deaths. Nonetheless, the FDA is taking the reports seriously because of the potential harm that the catheters could cause.
The company received reports that the product’s outer material separated from the catheter, causing it to break. This could lead to serious injuries because the fragments could remain in the bloodstream of the patient and cause major medical issues, such as blood vessel wall injuries, the development of blood clots, heart attack, embolism, blockage of blood vessels and even death. Even trying to recover these fragments can subject the patient to serious injury. Additionally, if the parts become detached, this can directly expose the consumer to the stainless-steel braid wires.
Products Affected by the Recall
The recall applies to 6 French Sherpa NX Active Guide Catheters that were manufactured between March 2017 and March 2019. These devices are usually used during coronary and peripheral interventional procedures to access a patient’s veins and arteries in and out of the heart. Doctors often use them to position guidewires and other medical devices during surgery. They may also use them to administer drugs or fluids to patients.
The manufacturer has contacted doctors to remove any unused catheters from their inventory and to return them to the company in order to avoid injury to patients. However, patients could have been negatively impacted by the catheters from the products that were already used during medical procedures.
Other Problems with Medtronic Catheters
This is not the first issue that Medtronic has experienced with its catheter products. In September 2019, the manufacturer notified healthcare providers of its voluntary recall of its balloon dilation catheters that were manufactured between February 2019 and July 2019. Medtronic recalled these catheter products after receiving reports about the difficulty to safely remove them. If medical providers need to exert extra force to remove the catheters, this could damage the balloon and result in inflation or deflation problems with the balloon.
This problem subjected patients to the risk of lengthened procedure time, vessel injury and the necessity for more medical intervention. One patient reported being injured due to the problem. Medtronic contacted healthcare providers and requested they return the products that remained in their inventory that were part of the recall.
Help for Injured Patients
If you were injured or hospitalized due to a defective Medtronic catheter or other defective medical device, you have rights. You may be able to file a product liability claim and seek compensation for your increased medical expenses, lost income and pain and suffering. An experienced defective product lawyer can discuss your rights during a free consultation. Contact us today to get started.
