Becker's ASC

FDA recalls Medtronic cardiac medical devices — 4 things to know

The FDA issued a Class I recall — the most serious recall classification — for some of Medtronic’s cardiac resynchronization therapy and implantable cardioverter defibrillators. Here are four things ...
Crain's Chicago Business

Durbin, Schakowsky take aim at medical device recalls

Illinois Sen. Dick Durbin and Rep. Jan Schakowsky want an electronic format for medical device makers to quickly and transparently report recall information to federal regulators to improve what they ...
CBS News

The FDA calls them "recalls," yet the targeted medical devices often remain in use

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — "a Class I recall, the most serious type," the FDA said. "Use of this device may cause serious injuries or death ...
Becker's Hospital Review

Philips recalls cardiac device software after 2 patient deaths

Philips is recalling the software associated with its mobile cardiac outpatient telemetry devices after 109 patient injuries and two patient deaths, a Jan. 13 FDA recall notice said. The software was ...
FierceBiotech

GAO probe finds understaffed FDA putting some medical device recall work on the 'back burner'

The FDA’s oversight of medical device recalls continues to be plagued by staffing challenges—forcing some activities to be placed on the “back burner” and resulting in lengthy response times, ...
JD Supra

Recalled Medical Devices: How to Check If You Have One

Numerous medical devices sold in the United States are subject to active recalls. If you have a medical device that is subject to an active recall, it will be important to make sure you know what this ...
Hosted on MSN

FDA rarely forces manufacturers to recall dangerous medical devices, GAO report says

This story was originally published by ProPublica. The FDA rarely uses its authority to pull dangerous medical devices off the market and is so poorly staffed that it's sometimes unable to make sure ...
The Town Talk

Beyond the Recall Notice: Understanding Long-Term Health Monitoring After Using Faulty Medical Devices

Receiving a recall notice for a medical device can be deeply unsettling for Louisiana residents who rely on these devices daily—whether for sleep support, pain management, or mobility—news of a recall ...
FierceBiotech

The FDA calls them 'recalls,' yet the targeted medical devices often remain in use

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device—“a Class I recall, the most serious type,” the FDA said. “Use of this device may cause serious injuries or death,” ...
ProPublica

The FDA Rarely Forces Manufacturers to Recall Dangerous Medical Devices, Watchdog Report Finds

ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. The Food and Drug Administration rarely uses its authority to ...
MM&M

The FDA calls them ‘recalls,’ yet the targeted medical devices often remain in use

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — “a Class I recall, the most serious type,” the FDA said. “Use of this device may cause serious injuries or death ...