Medical Device Network on MSN1d
Nearly a third of FDA medical device adverse event reports filed late
A new study found that 9.1% of medical device AEs were reported to the FDA 180 days later than required over a three-year ...
Becker's Hospital Review16h
3 medical device recalls and corrections
Medical device recalls are essential to patient safety, addressing critical issues in devices that may pose health risks. Here are some of the latest recalls reported to the FDA: ...
Modern Healthcare16d
Medical device recalls hit a four-year high in 2024. Here’s why
Medical device recall events in 2024 reached their highest level since 2020 and more than 10% of them involved the most ...
American Hospital Association3d
4 Steps to Improve Medical Device Recall Tracking
As of late February, there were 147 medical device recall events and 20 of them, or 13.6%, were Class I, according to a Modern Healthcare report.
More than 1.2 million medical device side-effect reports not submitted within legal timeframe, analysis finds
More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
Modern Healthcare9d
FDA labels Philips' recall of Tack Endovascular Systems a Class I
Complications with the implant used to treat blood vessel dissection after balloon angioplasty or stent placement can result ...
MassDevice1d
FDA says Intuitive da Vinci 5 foot pedal recall is Class II
Class II recalls — a grade below the most serious Class I recalls — reference a situation in which the use of or exposure to ...
MassDevice10d
Philips discontinues Tack endovascular system sales after serious recall
This recall involves removing devices from use and sale. According to the FDA notice, the device may cause serious injury of ...
Endovascular Today8d
Philips Recalls, Removes, and Discontinues Distribution of Tack Endovascular System
The FDA advised this week that Philips is recalling the Tack endovascular systems because of challenges experienced by customers d ...
Medical Design & Outsourcing11d
J&J MedTech’s Varipulse PFA recall investigation finds potential stroke factors
J&J's Varipulse PFA catheter recall investigation found the number of ablations, stacked ablations and ablation location may ...
JD Supra4d
Prescription Medical Device Manufacturers, Distributors, and the NABP: The Role in State Licensing
The National Association of Boards of Pharmacy (NABP) plays an important role in the state licensing of prescription medical device manufacturers ...