Page 3 - Device Events News Today

New York Times: 'The hardest part is seeing photos of myself, so I barely take any now.'

Cryolipolysis, the technical term for the procedure, involves placing a device onto a targeted part of the body to freeze fat cells. Patients typically undergo multiple treatments on the same area. In successful cases, the cells die and the body absorbs them.

CoolSculpting is among the most popular fixes for unwanted bulges. But the risk of a serious side effect appears to be higher than previously known.

CoolSculpting is among the most popular fixes for unwanted bulges. But the risk of a serious side effect appears to be higher than previously known.

Abbott and the FDA are telling health providers that the company's Trifecta family of heart valves could deteriorate early. 

Safety concerns led Philips Respironics to recall millions of respiratory machines. A year later, many are still using them despite the possible risks.

Healthcare

Inspectors repeatedly found manufacturing and device quality problems with the HeartWare heart pump. But the FDA did not penalize the company, and patients had the device implanted on their hearts without knowing the facts.

First published on Medtronics HeartWare HVAD pump system has been hit with a slew of recalls in recent months and the rate of device malfunction reports documented since its been on the market in an FDA database outpaces competing products. So far this year, the FDA issued three Class I recalls for the system, including issues with delayed or stalled restarts and updates to instructions for use. However, issues with the system go back to nearly as early as the product received its premarket app...