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When Medical Devices Malfunction
A colorful, digital illustration in pencil and watercolor shows a cartoon figure hooked up to an array of medical devices. The figure has a device in their mouth, which has caused two teeth to fall out; a glucose monitor on their arm is connected to a cellphone; a ventilator is connected to their lungs; a device is connected to their heart from the inside with battery packs on the outside; a hemodialysis machine causes blood to spurt from a vein unnoticed; and hip and knee implants are broken. Error symbols (a yellow triangle with a red exclamation point at its center) float in the background and around some of the devices.

When Medical Devices Malfunction

Americans trust the FDA to make sure medical devices are safe and to act swiftly if problems arise. But a year-long investigation by KFF Health News and CBS News revealed that a series of FDA-cleared products, both implanted in the human body and used to treat chronic diseases, have been suspected of contributing to thousands of injuries and patient deaths.

Featured Stories

Thousands Got Exactech Knee or Hip Replacements. Then, Patients Say, the Parts Began to Fail.

October 10, 2023

In a torrent of lawsuits, patients accuse Florida device maker Exactech of hiding knee and hip implant defects for years. The company denies the allegations.

A man with his arms crossed in leans against a white pickup truck parked in a driveway.

Deep Flaws in FDA Oversight of Medical Devices, and Patient Harm, Exposed in Lawsuits and Records

December 21, 2023

Thousands of medical devices are sold, and even implanted, with no safety tests.

A colorful, digital illustration in pencil and watercolor shows a cartoon figure hooked up to an array of medical devices. The figure has a device in their mouth, which has caused two teeth to fall out; a glucose monitor on their arm is connected to a cellphone; a ventilator is connected to their lungs; a device is connected to their heart from the inside with battery packs on the outside; and a hemodialysis machine causes blood to spurt from a vein unnoticed. A large error symbol (a yellow triangle with a red exclamation point at its center) is at the center of the illustration.

Patients Facing Death Are Opting for a Lifesaving Heart Device — But at What Risk?

December 19, 2023

The HeartMate 3 is considered the safest mechanical heart pump of its kind, but a federal database contains more than 4,500 reports in which the medical device may have caused or contributed to a patient’s death.

More From The Project

Patients Expected Profemur Artificial Hips to Last. Then They Snapped in Half.

December 5, 2023

The FDA and the manufacturer were alerted to Profemur titanium hips breaking inside U.S. patients as of 2005. It took 15 years to recall the devices. Many fractures could have been avoided.

Two photos shown side-by-side: On the left, a portrait of a man with his wide; on the right, an x-ray of a broken artificial hip.

‘It Was a Bloodbath’: Rare Dialysis Complication Can Kill, and More Could Be Done To Stop It

July 7, 2023

A venous needle dislodgment is a rare dialysis complication that can kill a patient in minutes. Some experts worry those who treat themselves at home are at increased risk.

A photo of an older woman standing for a portrait outside by a fence.

Dental Device Investigation

This Dental Device Was Sold to Fix Patients’ Jaws. Lawsuits Claim It Wrecked Their Teeth.

March 1, 2023

A dental device called AGGA has been used on about 10,000 patients without FDA approval or proof that it works. In lawsuits, patients report irreparable harm. The AGGA’s inventor and manufacturer have denied all liability in court.

Two photos are shown side by side. The left is of a young woman playing a clarinet at a concert. The right is of the same woman showing her misaligned teeth.

Feds Launch Criminal Investigation Into ‘AGGA’ Dental Device and Its Inventor

April 12, 2023

KFF Health News and CBS News recently reported that multiple lawsuits allege the device has led to grievous injuries to patients’ mouths, resulting in loss of teeth.

FDA Evaluates ‘Safety Concerns’ Over Dental Devices Featured in KHN-CBS Investigation

March 31, 2023

A KHN and CBS News investigation found that a dental appliance called the AGGA has been used by more than 10,000 patients, and multiple lawsuits allege it has caused grievous harm to patients.

FDA Looks Into Dental Device After KHN-CBS News Investigation of Patient Harm

March 15, 2023

The FDA’s interest in the AGGA dental device follows a KHN-CBS News investigation, according to a former agency official.

A photo of the AGGA device on a mold of teeth.

Credits

Reporters

Daniel Chang
Brett Kelman
Fred Schulte
Nicole Keller, CBS News
Anna Werner, CBS News

Data Reporter

Holly Hacker

Photographers

Eric Harkleroad
Matt Pendleton
Ash Ponders

Illustrator

Oona Tempest

Editors

John Hillkirk
Kelly Johnson
Sabriya Rice

Producers

Eric Harkleroad
David Hicks
Lynne Shallcross
Oona Tempest
Lydia Zuraw

Copy Editors

Terry Byrne
Gabe Brison-Trezise