Medical Device Recalls
Understanding Recalls, Product Advisories and Field Actions
Consumers seeking important safety information about their medical devices are often confused about the different terms that are used by specific manufacturers, the industry as a whole and the Food and Drug Administration (FDA). Attorney Neil Overholtz,
When Are Medical Device Manufacturers Required To Send Out Warnings?
Consumers have a right to know when any product is deemed unsafe or defective and responsible companies will inform their customers of potentially dangerous situations. That's not always the case with medical device manufacturers - and the lack of inform
Medical Device Recalls: The Importance of Consulting With an Attorney
Patients with medical devices subject to a recall are usually in the dark about what device was recalled, why it was recalled and what to do about the recall - and through no fault of their own. Medical device manufacturers often label recalls as 'produc
Medical Device Recalls: Why Are There So Many?
Medical device recalls seem to be increasing. In the past year, Medtronic, St. Jude, Boston Scientific / Guidant, Cardinal Health and a host of others have recalled medical devices - often putting patients at serious risk of injury or death. So, why are
Canada Certifies Class Action against Boston Scientific Over Faulty Defibrillators
Canada recently certified a class action lawsuit against Guidant (now Boston Scientific) for allegedly marketing known faulty defibrillators to nearly 2,000 Canadian citizens - over one quarter of who have already had to undergo risky surgery to replace t
Court Awards $40M to Man Whose Heart Was Burned By Medical Device
A California court recently awarded $40 million to a man whose heart monitor device malfunctioned and burned his heart - causing him to have a heart transplant. The verdict is thought to be one of the largest in the state.
Medical Device Safety Act: How It Would Affect Your Right to Sue
The proposed Medical Device Safety Act of 2008 would hold manufacturers liable for their devices by allowing victims to sue for their injuries in state court. If passed, it would essentially reverse the U.S. Supreme Court's decision earlier this year that prohibited lawsuits against manufacturers in situations where the U.S. Food and Drug Administration (FDA) was ultimately responsible for a medical device's approval before being released into the marketplace.
Medtronic Patient Dies From Unapproved Use Of Company's Infuse Bone Graft Product
A patient who received Medtronic Inc.'s Infuse bone graft died after going into respiratory arrest, falling into a vegetative state and was temporarily kept alive by artificial means. Her family is suing Medtronic alleging that her spine surgery involved an unapproved use of the product. However, the U.S. Food and Drug Administration (FDA) wants to know why the company never informed it of the death - something Medtronic was required to do.
Cardinal Health Warns Of Potential Health Risk With Alaris PC & PCA Infusion Devices
Cardinal Health, Inc. has issued an urgent safety warning regarding its Alaris PC & PCA Infusion devices which can potentially infuse above or below the intended infusion dose in certain cases. This is the latest in a string of warnings from the company about the safety of its products.
Welch Allyn Recalls 14,000 Defibrillators With Possible Fatal Flaws
Welch Allyn has recalled 14,000 of its automated external defibrillators after receiving reports of problems which could be fatal to users. Customers have been sent letters on what to do if they have one of the devices. Here are the details...
Top FDA Medical Device Regulator Resigns: Did He Put Industry Over Consumer Safety?
The U.S. Food & Drug Administration's (FDA) top medical device regulator, Dr. Daniel Schultz, says that he is resigning. The announcement comes after years of allegations by FDA doctors, researchers and members of Congress that Schultz favored medical device manufacturers over consumer safety.
Smith Medical Tracheal Tubes Recalled Due To Possibility Of Serious Injury Or Death
Smith Medical ASD, Inc., a New Hampshire based medical device manufacturer, has instituted a recall of Portex Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm) as some were incorrectly manufactured and could cause patients' airways to be partially or completely obstructed. Smith is working with the U.S. Food & Drug Administration (FDA), which has classified this as a Class I recall - meaning that there is a reasonable probability of serious injury and/or death.
Quick FDA Medical Device Approvals May Be A Thing Of The Past
One of the U.S. Food & Drug Administration's (FDA) responsibilities is to approve medical devices before they can be marketed. However, what many consumers don't realize is that not all medial devices go through a rigorous approval process if they are similar to devices already on the market. Known as a 510k review, this abbreviated process which allows medical device manufacturers to quickly launch their products, may soon be a thing of the past.
Former FDA Commissioner Accused Of Pushing Sketchy Medical Devices Through Approval Process
Former U.S. Food & Drug Administration (FDA) Commissioner, Andrew von Eschenbach, has been accused of using his Commissioner status to get a sketchy medical device approved. The situation, which involved lobbyists and members of Congress, seems more akin to a movie than to actual life - yet, many consumer advocate groups say that these types of relationships are all too common.