bad medical devices blog

The Chinese government says it will revoke the licenses of medical device makers that do not voluntarily recall products that have disastrous results, according to TradingMarkets.com.
If a medical device manufactured in China has a potential safety hazard and the company takes no action to notify the public or government, leaders there say they will impose […]

Mentor ObTape Vaginal Sling lawsuits are stacking up in Oklahoma, as three more women file suits against the California-based medical supply company. The vaginal sling, an artificial structure designed to replace eroded or weakened muscles in the urethra, was approved in 2003 to treat bladder incontinence. By 2006, the device was taken off the market.
As […]

Medtronic woes are mounting, both in the courtroom and now in Washington. Federal regulators have classified the move to inform physicians about an increase in the rate of inflammatory mass cases in patients receiving drugs through the company’s implantable infusion pumps as a Class I recall, Reuters reports.
A Class I recall signifies a situation in […]

There is growing debate about the re-use of certain medical devices, manufactured and labeled as single-use.
Medical device makers say the growing, cost-saving trend of recycling devices like scissors, scrubs and blades compromises patient safety. To be re-used, a labeled “single-use” device must be processed at a specific facility where it is sterilized and tested for […]

New guidelines for testing drug-coated stents are imminent, according to a report from Reuters.
The Food and Drug Administration is set to release new guidelines for the troubled medical devices that are causing blood clots at the location of implantation. The FDA’s device chairman released little details about the new guidelines but said it would […]

The FDA has posted its “Dear Colleague” letter regarding an update to earlier FDA safety information on Medtronic’s AneuRx Stent Graft. The notification re-emphasizes the need for continued surveillance of patients treated with endovascular grafts, and provides updated information on the mortality risks associated with the use of the AneuRx Stent Graft System to prevent […]

Stryker Corp. is already facing a mountain of legal woes in the United States over its recalled Trident Hemispherical and Trident PSL shell hip implants. Now, the company could be facing trouble in Oz.
The Age.com, an Australian magazine, reports of a man who feels Stryker could have done a better job of informing him and […]

New guidelines for the testing of drug coated stents will be released soon, the FDA said today. These guidelines will address the concern that drug coated stents are more likely to raise the risk of blood clots than the older bare metal versions.
Dr. Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health, […]

A case against Medtronic Inc., is back in a West Virginia court after it was transferred from a Minnesota federal court.
A lawsuit filed by the family of James LoFiego claims the medical device company participated in unfair competition, deceptive and fraudulent acts or practices as it failed to warn about the safety risks of its […]

The Washington Times reports a subsidiary of Stryker Corp. is under investigation for paying bribes overseas. Stryker recalled some of its defective hip replacements in January.
Stryker Orthopedics is one of five companies under investigation over a $230 million kickback scheme. Physicians were paid consulting fees to endorse or prescribe products made by Stryker. The U.S. […]