Boston Scientific Pulls Its Heart Device Off the Market
NATICK, MA -- December 9, 2005 -- Boston Scientific is recalling its vena cava filter, a heart device designed to prevent pulmonary embolism or blood clots that travel to the lungs (Press Release, December 2, 2005). The device can malfunction when it is being implanted, causing serious injury or death.
The recall applies to the Stainless Steel Greenfield® Vena Cava Filter with 12Fr Femoral Introducer Systems manufactured before March 10, 2004. It does not affect vena cava filters that have already been implanted in patients. Boston Scientific estimates that about 18,000 vena cava filters have not yet been implanted. The company sold the devices to hospitals throughout the world. The facilities will receive recall notification letters, including instructions on how to return recalled vena cava filters.
A vena cava filter is a small cone-shaped device that is implanted in the inferior vena cava, the large vein that carries blood from the lower part of the body to the heart. The filter is supposed to trap blood clots, allowing them to dissolve before they can reach the lungs. However, the bond between the carrier capsule and the outer sheath of the Greenfield® vena cava filter can separate during the implant procedure. If the carrier capsule detaches during an implantation, then pulmonary embolism may result. Boston Scientific received eight complaints about the vena cava filters-- two involved severe patient injuries and one resulted in death.
Other Recalls of Heart Devices
Other heart device manufacturers have had problems with their products this year. Last month, the New York Attorney General sued a leading medical device company, Guidant, for concealing information about major flaws in its Ventak Prizm 2 DR model defibrillators. A defibrillator is a surgically implanted device that provides a shock to the heart to restore it to normal rhythm. Earlier in the year, the company had recalled the Ventak Prizm 2 DR, as well as two other defibrillator models. All had been subject to short-circuiting, threatening the health and lives of heart patients.
In February, Medtronic Inc. advised doctors that the batteries in its cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) could become rapidly depleted, resulting in major injuries (Press Release, February 11, 2005). ICDs and CRT-Ds are devices that are surgically implanted into the heart. When working properly, ICDs shock the heart back into normal rhythm after patients suffer rapid heartbeat disturbances originating in the lower chambers of the heart. CRT-Ds also provide electrical pulses to the heart's two lower chambers to improve heart failure symptoms.
In March, Medtronic recalled its Lifepak 500 automated external defibrillators, which are used by non-medical personnel such as firemen and police to treat the injured. The Food and Drug Administration classified the recall as Class I, the most urgent recall in which there is a high probability of serious injury or death.
An automated external defibrillator shocks the heart to restore normal heart rhythm, but before it can deliver the shock, the device analyzes the patient's heart rhythm to see if a shock is appropriate. In some cases, the Lifepak 500 was unable to analyze the patient's heart rhythm, so that the shock to the heart did not occur. See the FDA recall notice for more information.
Injuries from Defective Heart Devices
Brayton Purcell is concerned about defective medical devices, and is currently evaluating these cases. Please feel free to contact us if you or a loved one has been injured and would like information about your legal options. We have been handling medically-related consumer cases for over 20 years, and have represented hundreds of clients against medical device manufacturers.