Boston Scientific Recalls Balloon Devices & Vena Cava Filter with Femoral Introducer Systems

If you are seeking an attorney in connection with a Boston Scientific balloon device or recalled vena cava filter and you or a family member have suffered injuries from a Boston Scientific device, please call us at 1.800.394.2119 or CLICK HERE to contact a lawyer for a free and confidential evaluation.

What You Should Know

On December 8, 2005 medical device maker Boston Scientific Corp. announced a recall of 40,000 implantable devices designed to treat blocked coronary arteries. Boston Scientific announced a worldwide recall of all Flextome Cutting Balloon® Device Monorail® Delivery System and Peripheral Cutting Balloon® Microsurgical Dilatation Device Small Monorail® Delivery System.The company had received eight complaints that the device became detached as it was removed from the patient and required more surgery in three cases. The recall affects all Flextome cutting angioplasty balloon devices that the Food and Drug Administration approved in September.

In a separate recall, on December 2, 2005 the company announced the recall of about 18,000 devices that filter and dissolve blood clots from entering the lungs. The recall was triggered by eight complaints that the capsule carrying the filter during implantation became detached from the delivery system, causing one patient death. Boston Scientific voluntarily recalled all Stainless Steel Greenfield® Vena Cava Filters with 12Fr Femoral Introducer Systems manufactured before March 10, 2004. This recall does not affect vena cava filters that have been implanted in patients.

The Boston Scientific Flextome cutting angioplasty balloon device differs from standard angioplasty balloons in that it is lined on the outside with lengthwise microsurgical blades. During angioplasty, a balloon catheter is snaked into a congested artery and inflated to reopen the blood vessel and push back accumulated plaque. The blades on the Flextome score the fibrous plaque as the balloon inflates, allowing for an easier compression.

The Flextome was approved in Europe in January. Boston Scientific has booked $13 million in Flextome sales during the year.

The company suffered balloon-related problems last summer when it had to recall thousands of its Taxus Express2 drug-coated stents after reports that the balloon used to place the stent did not deflate in some instances causing injury to the patient.

The recall marks Boston Scientific's second within a week. On December 2, 2005 the company announced the recall of about 18,000 devices that filter and dissolve blood clots from entering the lungs. The recall was triggered by eight complaints that the capsule carrying the filter during implantation became detached from the delivery system, causing one patient death.

What You Should Do

If you or a member of your family suffered a serious adverse reaction or injury after the use of a recalled Boston Scientific product it may be important to contact an attorney (we are located in Nashville, Tennessee but handle cases nationwide). We can help you protect your potential legal claim. If you would like more information, or would just like to talk with a lawyer experienced in this type of litigation, please call attorney David Randolph Smith at 1.800.394.2119 for a free consultation or CLICK HERE to send an email.

Our firm has years of experience in medical and product liability litigation involving drugs and devices. The firm has also prosecuted many wrongful death cases involving hypoglycemia and diabetes. If you are seeking a Tennessee medical malpractice attorney or a Tennessee product liability attorney, we would be pleased to hear from you.