Dr. David Gossman, who had worked at the Lahey Clinic Hospital since 1987, alleges he was terminated after speaking out about the financial relationship between Lahey Clinic and Medtronic Inc., reports Courthouse News.

In a lawsuit, Dr. Gossman alleges that the device maker proposed that Lahey Clinic have “access to the CoreValve, a new heart valve that will be in clinical trials in the U.S. soon, predicated on the purchase and increased utilization of other products made by Medtronic” quoted Courthouse News. According to Dr. Gossman, the offer violates “ethical guidelines,” said Courthouse News, and was made this summer to Dr. Thomas Piemonte—director of Interventional Cardiology and the Cardiac Catheterization Laboratory at Lahey Clinic. Dr. Gossman said Dr. Piemonte “has significant financial interest in Medtronic,” reported Courthouse News. (more…)

Cordis Corporation is recalling all lots of the Crossover Sheath Introducer due to complaints about stretching or fracture of the sheath during use.

To date, Cordis has received six complaints about the Crossover Sheath Introducer. No permanent patient injuries have been reported. In two instances, successful surgical intervention was performed to retrieve a portion of the sheath. (more…)

Stryker Biotech LLC has been indicted on federal charges of illegally marketing bone growth products called the OP-1 Implant and OP-1 Putty. According to a press release issued by the Acting U.S. Attorney in Boston, Mass., the company’s former president, Mark Philip, and its current sales managers, William Heppner, David Ard, and Jeff Whitaker were also indicted.

According to the press release, OP-1 Implant and OP-1 Putty, which were used to stimulate bone growth in long bones and the spine, were approved by the Food & Drug Administration (FDA) under a highly restrictive Humanitarian Device Exemption. One of the restrictions was that the device could only treat a condition that affected fewer than 4,000 patients in the United States, and could not be sold for a profit. (more…)

A voluntary nationwide recall was issued yesterday for all Accusure® Insulin Syringes manufactured by Qualitest Pharmaceuticals of Huntsville, Alabama.

The recalled syringes may have needles which detach from the syringe. According to the recall notice, if the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection. (more…)

Medical device manufacturers Hospira Inc. and Abbott Nutrition have submitted 122 reports of sparking, charring, and fires from faulty power cords used with their devices to the Food & Drug Administration (FDA). Those reports have prompted the agency to launch an investigation to determine if certain types of power cords used with medical devices may be defective.

The FDA’s investigation follows a recall of defective AC power cords manufactured by Electri-Cord Manufacturing Corporation issued by Hospira in August. Items included in this recall include several LifeCare and Plum products, along with the Oximetrix 3 SO2/CO Cardiac Output Computer, Nutrimix Micro Compounder and the GemStar Docking Station. Hospira began working with its customers the week of August 16 to replace all affected power cords regardless of their condition. (more…)

The manufacturers of certain types of pedicle screw systems, called dynamic-stabilization systems, have been ordered by the U.S. Food & Drug Administration (FDA) to conduct post-marketing studies on a number of potential safety issues. Sixteen companies, including Johnson & Johnson and Zimmer Holdings Inc., currently market these devices.

The FDA cleared the first dynamic stabilization system component in 1997. Dynamic stabilization systems are used in spinal surgery and some are intended to provide stabilizing support to the spinal column during bone fusion. Dynamic stabilization systems have different design features that allow bending or rotation while still facilitating fusion. (more…)

Certain units of the single-patient use Manual Pulmonary Resuscitator (MPR) have been recalled by Unomedical Inc. This recall is being conducted because of a potential malfunction of the MPR, which may impair the ability of the device to generate the positive pressure necessary to function properly. The occurrence of such a malfunction may create a situation in which the use of the product could potentially cause serious adverse health consequences or death.

Pulmonary resuscitators are used to administer artificial respiration to a patient while also giving an external cardiac massage. They are used during CPR to resuscitate patients suffering from cardiac arrest, and resuscitators use positive pressure to inflate the lungs of the patient while they are not breathing, in order to keep them oxygenated. (more…)

A new study has found that doctors who presented research last year at the annual meeting of the American Academy of Orthopaedic Surgeons weren’t always as forthcoming as they should have been about their financial relationships with the manufacturers of artificial joints. The study appears this week in The New England Journal of Medicine.

The financial relationships between the medical industry and doctors have caused controversy in recent years. In 2007, a U.S. attorney in New Jersey filed criminal complaints alleging that some of the largest artificial-joint makers conspired to violate a federal anti-kickback statute by making payments to surgeons in an attempt to keep their business. As we reported the time, four of the companies, Biomet Inc., DePuy Orthopaedics, Smith & Nephew, and Zimmer Holdings Inc. – paid a total of $310 million, without admitting wrongdoing. A fifth manufacturer, Stryker Corp., cooperated with the probe and was not charged. (more…)

Even though medical device recalls have increased in recent years, the Food & Drug Administration (FDA) has not devised an effective process for notifying the public about dangerous devices. According to an Associated Press report, lack of such a process has put patients in danger.

In 2008, 2,500 defective medical devices were recalled. More than 1,000 recall notices were sent out in the first seven months of 2009 involving medical devices, and of those recalls, 100 were deemed Class I. A Class I recall is the FDA’s most serious recall, and is issued when there is a “reasonable probability of adverse health consequences or death.” But finding these recalled devices is no easy task, particularly after they have been implanted into someone’s body. (more…)

Approximately 5,400 HeartStart FR2+ automated external defibrillators (AEDs) are being recalled by Philips Healthcare. According to the recall notice, a potential memory chip failure may render the device inoperable.

The HeartStart FR2+ defibrillators are used by trained responders and designated response teams to help treat sudden cardiac arrest. The device automatically analyzes the heart rhythm and determines whether a defibrillation shock is needed. If a shockable rhythm is detected, the FR2+ instructs the responder to deliver defibrillation therapy. (more…)