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The Food and Drug Administration (FDA) recently announced that medical company Medtronic is recalling over 106,000 catheters in the U.S. The administration has identified this as a Class I recall, which is the most serious type of recall, and indicates that use of these devices may cause serious injuries and/or death.

The recall follows a series of complaints about the catheters not performing as expected.

Medtronic Recalls Defective Catheters

The recall affects 6 French Sherpa NX Active Guide Catheters, which are used during coronary and peripheral interventional procedures to access veins and arteries inside and outside of the heart. Doctors may use them to place guidewires and other devices or to administer drugs or fluids into blood vessels.

The company initiated the recall in response to receiving at least five customer complaints of the catheters breaking, though no serious injuries or deaths were reported. The problem is that the outer material on the catheter may separate from the device, resulting in detached fragments that could expose the underlying stainless-steel braid wires.

The detached fragments could be left inside the patient’s bloodstream, which could cause other serious consequences like an injury to the blood vessel wall, development of a blood clot, blockage of the blood vessel, embolism, heart attack, or death. Attempts to retrieve these fragments may also cause serious injury.

Medtronic has sent an urgent medical device recall to doctors telling them to remove any of the affected catheters from their inventory and to return them to Medtronic. All models of the catheters manufactured between March 10, 2017, and March 14, 2019, are affected.

Doctors can call Medtronic at 1-888-283-7868 for more information on the recall, and patients may also contact the company at 1-877-526-7890.

Though the FDA and Medtronic are now working to get these products out of the healthcare system so they can’t harm patients, some patients may have already been affected by the defective catheters. If you underwent a coronary or peripheral interventional procedure and were injured or hospitalized, or if a loved one suffered from wrongful death, you may be eligible to file a personal injury lawsuit.

Medtronic Also Recalls Balloon Dilatation Catheters Due to Potentially Difficult Removal

This isn’t the only problem Medtronic has had with its catheters. In September 2019, the company sent an urgent field safety notice notifying doctors and other healthcare professionals that it was voluntarily recalling a specific subset of Euphora and Solarice Semi-Compliant Rapid Exchange Balloon Dilatation Catheters manufactured from February 27, 2019, through July 31, 2019.

The company determined that some of the catheters had a slightly higher diameter stylette, which could make it difficult to remove them. If doctors had to apply extra pressure to pull them out, they could damage the balloon which could lead to balloon inflation or deflation challenges. Potential risks to the patient included prolonged procedure time, the need for additional intervention, and vessel injury.

Medtronic received customer complaints about these catheters, particularly related to the difficulty of removing them. The company also had received one report of patient injury related to the problem. The company urged healthcare facilities to return all unused affected products to Medtronic.

 

 

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