Class 1 Recall for Component of Newly Approved Medtronic Heart Device

Medtronic’s EnVeo R Loading System, used with the CoreValve Evolut R system for transcatheter aortic valve replacement (TAVR), has been recalled.

Medtronic’s EnVeo R Loading System, used with the CoreValve Evolut R system for transcatheter aortic valve replacement (TAVR), has been recalled.


Medtronic has announced the voluntary recall of the EnVeo R Loading System, a component in the CoreValve Evolut R system for transcatheter aortic valve replacement (TAVR), less than two months after the device received Food and Drug Administration (FDA) approval.

The recall came after Medtronic received eight reports of the presence of particulates in the EnVeo R Loading System. The particulates could “be transferred to the transcatheter aortic valve and released into the patient’s vasculature,” potentially resulting in clot formation and blockage of the valve, Medscape reports.

In two of the reports, the particulates were noticed in the packaged kits. In the remaining reports, the particulates were seen by someone who was loading the bath. No injuries or adverse events have been reported to date, Medtronic said in its letter notifying customers of the problem. A Medtronic representative said none of the affected loading systems were released commercially in the U.S. and they were being used only in clinical trials. All units have now been removed from the market, Medscape reports.

The Evolut device received FDA approval in June for transaortic valve replacement (TAVR) in patients with severe aortic stenosis — a narrowing of the aortic valve. Traditional open-heart surgery is too risky for these patients. TAVR is a fairly new heart procedure, a minimally invasive technique to repair the aortic valve without removing the old valve, the American Heart Association explains. Particulates in the loading system could be transferred to the patient’s blood stream, leading to a blockage that could have serious health consequences, Medtronic said in its letter to customers.

The recalled EnVeo R units are the EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, and LS-EnVeoR-2629-C. The cardiovascular valve delivery system is for use with the Medtronic CoreValve Evolut R system. Medtronic notified health care professionals about 6,912 EnVeo R Loading System units in the field, of which 540 were in the U.S. Only certain lots of the loading system were affected and Medtronic told customers how to contact the company about those. But, the letter said, “Medtronic is not making any special patient management recommendations; patients should continue to be managed in accordance with your standard patient-management protocol.” According to a Medtronic representative, the particulate issue has “now been resolved with the introduction of a process improvement in manufacturing,” Medscape reports.

This recall has been designated as a Class 1 recall, the FDA’s most serious recall category. In a Class 1 recall, there is a “reasonable probability” that use of the product can cause serious health consequences or even death.

Medtronic has instructed customers to remove the recalled EnVeo R units from inventory and to inform any other facilities to whom they may have sent units. The FDA recall notice said customers should complete the customer confirmation certificate and to email RS.CFQFCA@Medtronic.com or fax Medtronic at (651) 367-0612 to the attention of Customer Focused Quality for further instructions.

After Inspections Reveal Contamination Issues, EMA Conducts Review of Medtronic’s InductOs

EMA Conducts Review of Medtronic’s InductOs

EMA Conducts Review of Medtronic’s InductOs


Medtronic’s implantable bone development product InductOs is under review by the European Medicines Agency (EMA) in light of contamination problems as a US site where one of the components are manufactured. InductOs is used to stimulate bone growth in patients undergoing spinal fusion in the lower back and in surgeries to repair broken tibia. The component that may be contaminated is the absorbable collagen sponge (ACS) manufactured by Integra LifeSciences. InductOs is sold as a kit containing the ACS and its active ingredient dibotermin alfa.

Regulatory Affairs Professionals Society (RAPS) reports that inspectors found contamination problems at a US site manufacturing the ACS in January 2014. The inspection uncovered “a number of major deficiencies” and Integra was issued a corrective action plan. This led to a restriction on the import of the sponge to the EU until inspectors could return and “assess the progress in eliminating the major deficiencies”. [Read more…]

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…]