bad medical devices blog

The FDA has officially classified as a recall a safety alert involving an implantable drug pump that Medtronic Inc. had issued in June. One patient has died, and 83 patients have experienced improper connections between implanted catheters and pumps that deliver infused drugs.
The improper connections can result in leaks of pain drugs that can cause […]

Republican Sen. Charles Grassley, an outspoken member of the Senate Finance Committee, wrote a stern letter to the National Institutes of Health over his worries about a Tufts University professor’s ties to the medical device industry.
Marvin Konstam is a professor at Tufts University and is also director at Orquis, a medical device maker. He is […]

A Medtronic lawsuit brought by a former lawyer of the medical device maker alleges that Medtronic gave surgeons a variety of perks to use its devices. According to the Wall Street Journal, these perks included regular entertainment at a Memphis strip club, trips to Alaska and patent royalties on inventions they played no part in.
The […]

A CBS News investigation found that dental work like crowns and bridges have tested positive for high levels of lead.

The problem exists in that there is no federally-allowable minimum amount of lead that can be included in dental work.
In this investigation, CBS reporters in Columbus, Ohio, purchased 13 crowns from labs in China. Many dental […]

Consumer-directed advertisements for medical devices can be misleading, some lawmakers say. According to the New York Times, some lawmakers, medical groups and others are calling for restrictions on such advertisements, claiming they mislead patients.
On Wednesday, the Senate Special Committee on Aging plans to hold a hearing about direct-to-consumer promotions of medical devices. Dr. Bozic, who […]

Medtronic’s deep pockets are putting the medical device company under scrutiny once again, this time with a congressional investigation and a federal lawsuit alleging that at least eight Minnesota doctors are accepting kickbacks from Medtronic. The lawsuit, filed last year in U.S. District Court in Massachusetts, accuses the paid doctors of overusing Infuse, a bone […]

The FDA has announced a Class 1 recall of LifePak CR Plus Automated External Defibrillators, product numbers 3200731-003 and 3200731-027, for a manufacturing defect which could result in death. The AED instructs the responder, by voice prompts, to press the shock button. However, the shock button is covered and is not visible. Therefore, the responder […]

The FDA on its website today reprinted an article from August Nursing2008 highlighting safety hazards that can result from cutting the battery pack cable on a disposable lavage system.
After a patient had a wound debridement procedure in the OR with a disposable battery-operated lavage system (BOLS), she was transferred to the postanesthesia care unit. […]

The Star Tribune reports that when medical device salesman John Thomas heard in late 2000 that there was a new doctor in Arkansas specializing in patients with ailing backs, he stopped by his office to see if the two could do a little business. The would-be customer, Dr. Patrick Chan, said he was partial to […]

Nearly a year after Medtronic’s Sprint Fidelis Leads were recalled for shocking heart patients to death, the FDA announced today the approval of a software update from Medtronic that will help detect fractures of the company’s Sprint Fidelis cardiac defibrillator lead. The new software package’s purpose is to alert both patients and physicians of a […]