Search Results for "medtronic"
- Medtronic Braces as Additional Problems Found with HeartWare Device
Anyone familiar with the process of buying a pre-owned vehicle knows how important the test drive is. Not only is this the time when you get a feel for it and see how it handles, but it is also the purchaser’s chance to determine if the vehicle is running properly. Your ears listen to the engine f...
- Medtronic Under Fire for Slow Insulin Pump Fixes
The Food and Drug Administration recently notified executives at medical device manufacturer Medtronic that its efforts at rectifying significant issues within its diabetes business are falling short. “In summary,” the agency said, “your corrective actions are still in process, and you have no...
- Medtronic’s Diabetes Unit Gets a Warning Letter from the FDA
Medtronic has recently notified the public that it received a warning letter from the FDA over quality control concerns at its diabetes unit. Included within that letter were issues related to the corporation’s risk assessment, its propensity for device recalls, and the way it handles complaints t...
- Medtronic Heart Catheter Recalled After Injuries, Deaths
A recall has been issued for the Medtronic Rashkind balloon septostomy catheter. 142 of the devices are covered under the federal recall action and were distributed throughout the United States between May 2018 and August 2020. According to the FDA, the recall was issued because “quality issues…...
- Medtronic Sees Class I Recall Over Faulty Insulin Pumps
Medical device manufacturer Medtronic is back in the news but this time it’s not for their surgical staplers. The company has recalled some 322,000 MiniMed insulin pumps over concerns that they may be missing a critical component, or that those that have the component might actually be broken. The...
- Medtronic Stapler Litigation Shows Ties to Secret FDA Database
When news broke of an internal FDA database of medical device injuries so secret that few within the agency even knew of its existence, the discovery obviously led to the raising of a multitude of questions. Why was an agency tasked with keeping American families safe allowing the companies it was s...
- Medtronic Heart Pump Recalled Over Potentially Fatal Flaw
Last year, medical devices manufacturer Medtronic bought HeartWare, the company behind a heart pump known as the HVAD system. The deal cost Medtronic $1 billion. Prior to the purchase, HeartWare had received not one, but two safety letters from the U.S. Food and Drug Administration over issues relat...
- Medtronic Issues Worldwide Recall of Covidien Shiley Tracheostomy Tubes
Ireland-based medical device company Medtronic has issued a worldwide recall of certain lots of its Covidien Shiley neonatal and pediatric tracheostomy tubes. According to the U.S. Food and Drug Administration (FDA), Medtronic announced on May 8 that it had begun “notifying hospitals and distribut...
- Humana Sues Medtronic for Paying Doctors to Promote Infuse for Improper Use
Health Insurer Humana Inc. is suing Medtronic Inc. alleging the device manufacturer paid $210 million to market its Infuse bone-graft drug to doctors for improper use. Humana claims the doctors then pushed the use of Infuse for use in certain neck and spine surgeries, which is not approved by the FD...
- Legal inquiries ongoing into Medtronic Infuse bone implant
Despite Minnesota-based Medtronic’s announcement that the federal government has closed its investigation into the marketing of a bone growth agent called Infuse, the company’s legal troubles are not over. According to an article in the Pioneer Press, a number of other legal inquiries are ongoin...
