bad medical devices blog

A Harvard cardiologist, along with researchers from the University of Massachusetts and University of Washington, have successfully hacked an implantable defibrillator device.
The research team, however, said this should not serve an immediate concern to patients with these implanted devices.
“We just want the industry to be thoughtful about where we as a society are going with […]

Associated Press reports tens of thousands of Gulf Coast children who lived in FEMA trailers could face a lifelong bout of illness.
It reports of a Louisiana mother who lived in a trailer while pregnant with her now-15-month old daughter.
Her daughter now faces a long bout of severe asthma and must inhale medicines through a device.
Formaldehyde […]

Medtronic Spine LLC has agreed to a $75 million settlement on a whistleblower lawsuit which exposed the company’s sales and pricing strategy which defrauded Medicare while boosting profits.
The Federal government joined the “qui tam” lawsuit and details of the lawsuit were removed from confidentiality when Medtronic settled the suit which is a carry over from […]

The Bucks County Courier Times reports a doctor who was first taken aback by one of his patients who he heard walking into the examination room.
The patient didn’t have a lead foot, but more of a squeaking hip.

According to a 2006 study, 10 in every 143 hip replacements using ceramic on ceramic hip implant parts […]

The Supreme Court is expected to rule in favor of the medical device industry this fall, basically barring state courts and juries from awarding plaintiffs any rewards in cases regarding FDA-approved devices.
The decision let negligent medical device makers off the hook from litigation in cases where their products injured or caused the death of patients.
But, […]

Results of two heart patients surveys indicate that not all folks implanted with defective defibrillators recalled were informed that the devices meant to save their lives might kill them.
Recent recalls of implanted defibrillators have forced some patients to have them removed. The devices deliver jolts to the heart that reset its electrical system when […]

An editorial in the New England Journal of Medicine says regulators should take a close look at a 60-second ad for the Cypher heart stent, made by Cordis, a subsidiary of Johnson & Johnson.
The author of the article says the ad doesn’t do much to highlight the potentially serious health risks posed with the Cypher […]

In connection with the massive heparin recall, heparin coated medical devices are now being added to the list of potentially deadly items. Atrium Medical Corporation has announced a recall of selected lots of HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters, due to the fact that some lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with […]

Medtronic has announced it is planning a global study comparing its new drug coated stent Endeavor against Abbott’s drug coated stent Xience V. The study will enroll 2,300 patients, and hopes to look into several factors that lead to cardiac death, the Minneapolis / St. Paul Business Journal reported this week.
Medical device maker Medtronic recently […]

The Food and Drug Administration sent a warning letter, dated May 2, to Immucor Inc., regarding problems with the manufacture of its blood testing products.
The FDA says the company “failed to establish and maintain procedures to control product that does not conform to specified requirements.”
Reuters reports the FDA is citing the company for sending out […]