Device Safety

Latest Headlines

Latest Headlines

The metal-on-metal hip legal saga round one (of 6,000?): J&J vs. Herlihy-Paoli

Johnson & Johnson squared off with aggrieved metal-on-metal hip customer Kathleen Herlihy-Paoli in a case that the plaintiffs says could lead to a $5 billion-plus payout. Herlihy-Paoli's claims that the hips leaked metal into her bloodstream, leading to an infection that required the artificial hip to be removed.  

FDA issues largest one-day recall ever for 233 products

Customed received the most serious recall the FDA hands out--a Class I recall. This recall is the largest across-the-board recall the FDA has ever issued to date, 9 times larger than the previous record holding recall.

Pew report makes recommendations on improving data registries

To improve postmarket monitoring of medical devices, three prominent stakeholders released a report today on the optimal use of medical device data registries to enable postmarket surveillance.

J&J shoring up for latest courtroom battle over all-metal hip implant

Long beleaguered by claims related to defective all-metal hip implants, Johnson & Johnson is shoring up for its latest courtroom battle as the company faces the first trial for one of its artificial hip devices.

Boston Sci gets bad news on four of 23,000+ vaginal mesh lawsuits

Boston Scientific faces more than 23,000 lawsuits over its Pinnacle transvaginal mesh device. Last week it failed to remove four cases from a consolidated multidistrict litigation suit in the U.S. District Court for Western Virginia.

FDA allows Covidien to restart manufacturing of two recalled devices

The FDA approved Covidien's fixes to the manufacturing process of its recalled Pipeline Embolization Device and Alligator Retrieval Device for treating brain aneurysms.

NY Senators tell FDA to stop sales of power morcellators

Democratic Sens. Chuck Schumer and Kirsten Gillibrand of New York urged the FDA to remove all power morcellators from the market in a letter to FDA Commissioner Margaret Hamburg.

FDA targets off-label use of intranasal splint, with safety alert and Class I recall notice

The FDA continued its attack on Enhancement Medical LLC's Expression intranasal splint, designating the product's July recall as Class I.

Home healthcare design considerations addressed in FDA final guidance

The migration of medical devices to the home poses new and unique challenges, prompting the FDA to finalize its guidance on design considerations for devices intended for home use (or "home healthcare"), issued today.

Ablatherm ultrasound prostate cancer treatment rebuffed by FDA panel

The FDA's Gastroenterology & Urology Devices panel came down firmly against EDAP's Ablatherm system for treating low-risk, localized prostate cancer. The panel voted 9-0 on the device's effectiveness, 5-3 against its safety (with one abstention) and said the risks outweigh the benefits by a vote of 8-0 (with one abstention).