Class 1 Recall Issued for Medtronic Tracheostomy Tubes

Class 1 Recall Issued for Medtronic Tracheostomy Tubes

Class 1 Recall Issued for Medtronic Tracheostomy Tubes


Medtronic’s Shiley Neonatal and Pediatric Tracheostomy Tubes have been recalled following reports of breathing issues when switching tubes to newer models. A tracheostomy is performed when the surgeon needs to create an opening in the patient’s trachea, or windpipe. The recalled tubes, which include the Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff, provide an airway and remove secretions from the lungs. These devices are used in children and infants.

According to a recall alert posted on the U.S. Food and Drug Administration’s (FDA’s) website, the tubes are being recalled because Medtronic received reports of patients who experienced airway obstruction when their previous Shiley tracheostomy tubes were switched to a newer model. This may have occurred because the newer tubes have differences in their angles, and “Since each patient has their own distinct anatomy and their trachea may have become accustomed to the inserted tube, changing the tube, particularly to one with a different angle, may cause airway obstruction.” according to the alert. [Read more…]

Medtronic MiniMed Recalls Insulin Pumps Over Problem with Bolus Screen

Medtronic MiniMed Recalls Insulin Pumps

Medtronic MiniMed Recalls Insulin Pumps


Medtronic MiniMed has announced the recall of nearly two thousand MiniMed 640G insulin pumps, mostly in Europe, because of difficulties with a screen not properly timing out.

The affected pumps were distributed in 10 European countries and Australia, according to the recall notice just issued by the Food and Drug Administration (FDA). This insulin pump model was launched in Europe in January and is slated for an FDA premarket approval application submission later this year, FierceMedicalDevices reports. [Read more…]

Medtronic Continues to Pay Millions of Dollars to Doctors who Authored Questionable Research Articles About InFuse Bone Growth Product

Medtronic Continues to Pay Millions to Doctors

Medtronic Continues to Pay Millions to Doctors


New federal data show medical device maker Medtronic is still paying millions of dollars to doctors who provided sketchy research on the company’s controversial Infuse spinal product.

StarTribune.com reports that Medtronic’s spine division, Medtronic Sofamor Danek, paid $60.7 million in royalties to 79 doctors and their affiliates in 2014. Some of that money went to the authors of dubious studies of Infuse, a product that has become the subject of hundreds of patient injury lawsuits. Medtronic paid $374,000 in royalties last year to Georgia surgeon Dr. Ken Burkus. Burkus was the lead author on six studies that omitted adverse events related to Infuse. Atlanta, Georgia, neurosurgeon and lead author of one of the studies, Dr. Regis Haid, received $2.3 million. Payments for both were sent to third-party companies. Medtronic paid a total of $90 million in royalties in 2014. [Read more…]

Thousands of Tracheostomy Tubes Intended for Children and Babies Recalled

Thousands of Tracheostomy Tubes for Children Recalled

Thousands of Tracheostomy Tubes for Children Recalled


Medtronic has recalled 70,000 of its Covidien Shiley tracheostomy tubes for children and babies after receiving reports that some patients had difficulty breathing with them.

In 2012, Medtronic altered its Covidien Shiley tracheostomy tubes to give it a wider angle. Since that time, regulators have received hundreds of adverse event reports concerning the device. In a statement issued on Tuesday that was obtained by StarTribune, Medtronic said that switching back to models predating the design change seemed to address the young patients’ breathing issues. [Read more…]

The Fortune 500 Drops Medtronic From the List After the Company Sets up its Headquarters in Ireland

Fortune 500 Drops Medtronic From the List

Fortune 500 Drops Medtronic From the List


Medtronic’s move to Ireland has prompted Fortune to kick the company off of its Fortune 500 list. The company would have been number 185 on the list.

The company was acquired by Dublin, Ireland-based medical device maker Covidien for $42.9 million, but continues to operate its headquarters in Minneapolis, Minnesota. Under current law, U.S corporations pay taxes to whichever nation its domicile resides in, but companies can easily bring those profits back to the U.S. without them being taxed at higher rates, according to MinnPost. Medtronic CEO Omar Ishrak told the Financial Times in June of last year that this was the company’s goal. [Read more…]