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Medtronic Facing Problems with Two Medical Devices

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

Medtronic, the Irish medical device manufacturer whose headquarters in the US are in Minneapolis, is facing renewed scrutiny concerning two of its products-the Medtronic Harmony delivery catheters and Medtronic NIM Standard Reinforced EMG Endotracheal Tubes and Medtronic NIM Contact Reinforced EMG Endotracheal Tubes.

Hundreds of Medtronic Harmony delivery catheters are being recalled because the end of the catheter may break off during insertion, resulting in serious and potentially life-threatening adverse health consequences for patients.

The FDA announced the Medtronic catheter recall on April 26, warning that the bonding on the capsule at the end may break during valve replacement surgery among children and adults.

To date, Medtronic has received at least six reports of the capsules breaking away from the catheter, resulting in at least one injury. Although no deaths have been reported, the FDA is warning healthcare professionals to stop using the devices immediately to prevent further injuries, or fatal outcomes.

Federal regulators are warning doctors there may be a risk of brain damage from Medtronic silicone-based endotracheal tubes, following reports of patient injuries and deaths.

The U.S. Food and Drug Administration (FDA) sent a letter to healthcare providers on April 27, warning of airway obstruction risks linked to Medtronic NIM Standard Reinforced EMG Endotracheal Tubes and Medtronic NIM Contact Reinforced EMG Endotracheal Tubes. The agency did not indicate how many patient injuries or deaths were associated with the devices, or whether there would be a Medtronic EMG Endotracheal Tube recall.

The tubes are inserted into the trachea to feed oxygen and remove carbon dioxide directly from the lungs to help patients breathe. These tubes also have electrodes for monitoring nerves and the laryngeal musculature. The Medtronic NIM tubes are the only silicone-based EMG tubes marketed in the U.S. and the FDA indicates reports suggest the silicone tubes are more prone to airway obstruction incidents.

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