The U.S. Food & Drug Administration (FDA) has warned medical device giant, Medtronic Inc., that it may have waited too long before recalling its Synchromed II Pumps – placing patients in grave danger.
FDA warning
Late last year, the FDA inspected Medtronic's plant in Puerto Rico where its Synchromed II Pumps, implantable devices used to deliver medication to the spine, are made. It concluded that the company failed to establish and maintain quality controls in its manufacturing process. Specifically, the FDA said that the company failed to fill the devices with a propellant before they were released into inventory.
Medtronic later discovered the error and recalled approximately 13,000 of the devices. However, its recall was not timely and some people had to have the pumps surgically removed. The FDA also stated that the company failed to review, evaluate and investigate complaints of possible problems with the product and allowed an employee who lacked expertise to make evaluations about company products – which it said could have caused serious injury or death. In a warning letter to the company, the FDA stated:
[We are] concerned with your failure to initiate a recall for devices affected by the propellant problem in a timely manner. It took almost two years from when the missing propellant was initially identified to conduct a recall.
Recalls and product liability lawsuits
Medtronic has been the focus of various recalls and product liability lawsuits over the past few years. Some of those products include:
In addition to those recalls and product liability lawsuits, the U.S. Securities & Exchange Commission (SEC) is investigating the company over its alleged practices of paying doctors to recommend its products by paying them consulting fees and providing them with other perks.
