Medtronic Inc.’s stated failure rate for the recalled Sprint Fidelis defibrillator lead has been disputed by some leading hospitals. According to a report in The Wall Street Journal, those hospitals – including the University of Rochester in New York state, the Minneapolis Heart Institute, the Mayo Clinic and the University of Ottawa – say the real fracture rate for the Sprint Fidelis is as much as two times greater that what Medtronic has publicly disclosed.

A lead is a wire that connects an implantable defibrillator to the heart. If a lead breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. More Sprint Fidelis Fracture Rates May be Higher than Medtronic Admits

Cardiac Science Corporation has just implemented a worldwide recall after it determined that about 12,200 automated external defibrillators (AEDs) may not be able to deliver therapy during a resuscitation attempt. This defect could lead to serious adverse events or death.

The recalled AEDs were manufactured in a way that makes them potentially susceptible to failure under certain conditions. The U.S. Food and Drug Administration (FDA) has been informed of this situation, said Cardiac Science Corporation. More Cardiac Science Recalls Faulty Defibrillators

The Recovery IVC Filter and G2 IVC Filter System manufactured by C.R. Bard and Bard Peripheral Vascular, Inc. have been named in several lawsuits filed by people who claim the devices failed, causing them to sustain serious and life-threatening injuries. Lawsuits allege that the Recovery IVC Filter and G2 IVC Filter System are prone to fracturing, and often, the fractured components migrate to other organs in the body, including the heart and lungs.

IVC filters, also known as inferior vena cava filters, are medical devices that are implanted in the inferior vena cava vein in order to filter blood clots that travel from the lower portions of the body to the heart and lungs. The Recovery IVC Filter was approved by the U.S. Food & Drug Administration (FDA) in 2003, but voluntarily removed from the market in 2005. It was replaced by the G2 IVC Filter system, which was modified to reduce filter fracture and migration. Both Bard IVC Filters are of the retrievable type, and on average were removed after being in the body for a couple weeks. More Lawsuits Claim Bard IVC Filters Caused Serious Injuries

Pain pumps, including those made by I-Flow, Stryker and Sorenson, have been associated with painful and debilitating shoulder injuries. Lawsuits have been filed around the country by people who claim they developed Post Arthroscopy Glenohumeral Chondrolysis (PAGCL), following the use of one of these devices. PAGCL is a relatively rare condition in which joint cartilage in the shoulder dies following the use of I-Flow, Stryker, Sorenson and other brands of pain pumps.

Commonly called intra-articular pain pumps, devices made by I-Flow, Stryker, Sorenson and are used after surgeries to deliver local anesthetics to a specific area through a plastic tube. Such pain pumps became popular with orthopedic surgeons in the late 1990s because they were seen as an alternative to extended hospital stays and safer than prescribing narcotic painkillers. However, they were never actually approved by the Food & Drug Administration (FDA) for use in joint surgery. More I-Flow, Stryker, Sorenson, Other Pain Pump Manufacturers Face Lawsuits Over Shoulder Injuries

Hettich Instruments Management Inc. has recalled Hettich Centrifuges with 2050 and 2076 Plastic Rotors, the U.S. Food and Drug Administration (FDA) just announced. Hettich Instruments Management I is located at 100 Cummings Center; Suite 130G;
Beverly; Massachusetts; 01915-6127.

This recall is a Class I. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the recalled products will cause serious adverse health consequences or death. The recall of Hettich Centrifuges was initiated on November 21, 2009 and includes the following products: More Hettich Instruments Recalls Centrifuges

Edwards Lifesciences Inc. initiated a Class I recall for its Aquarius Hemodialysis System, effective January 11, 2010, the U.S. Food and Drug Administration (FDA) just announced. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the recalled products will cause serious adverse health consequences or death.

The recall involves the Edwards Lifesciences Inc. Aquarius Hemodialysis System in model numbers GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04. This product was manufactured from July 12, 2007 through March 18, 2009 and distributed from July 12, 2007 through March 18, 2009. Edwards Lifesciences, LLC is located at 1 Edwards Way; Irvine, California; 92614-5688. More Aquarius Hemodialysis System Subject to Class I Recall

The U.S. Food and Drug Administration just announced a public meeting, to be held on February 18, 2010, to discuss key challenges related to pre-market notification, or the 510(k) process, used to review and clear certain medical devices marketed in the United States. The FDA receives more than 3,000 510(k) submissions annually.

As we have previously written and the Associated Press (AP) noted last year, scientists under former medical device head, Daniel Schultz, claimed, “they were pressured to approve certain products” against their best judgment. It was a nine-scientist letter that added to the call for reform at the agency. Following the letter, a number of lawmakers called on the FDA to investigate the alleged corruption, reported the AP. Schultz who managed the division for five years, ultimately resigned, said the AP. More FDA Sets Hearing To Discuss Medical Device Approvals

A Class I recall has been issued for Exel/Exelint Huber infusion set needles manufactured by Nipro Medical Corporation for Exelint International Corporation. Class I recalls are the Food & Drug Administration’s (FDA) most serious recall action, and involve situations in which there is a reasonable probability that use of a product will cause serious adverse health consequences or death.

Huber needles are used to access ports implanted under the skin of chronically ill patients for repeated access to veins for the withdrawal of blood and infusion of medication, nutritional solutions, blood products, and imaging solutions. The recall is being conducted due to ‘coring’, the cutting or dislodging of silicone cores or slivers from the ports into which they are inserted. More Huber Needles Recalled for “Coring” Problem

A Las Vegas patient just filed a lawsuit over a potentially defective pain pump, said the Las Vegas Business Press. The case was filed by Dorothy Vialpando and her husband, Gabriel, and alleges that Mrs. Vialpando’s shoulder cartilage was injured after 2006 implantation of a Stryker Pain Pump device, said the LV Business Press. Other similar suits are in progress nationwide against Stryker.

The lawsuit was filed in federal court and names both the international company Stryker and Stryker Sales Corp. and claims strict product liability, reported the LV Business Press. The lawsuit alleges that sales representatives from Stryker promoted the Pain Pump for uses not approved by the U.S. Food and Drug Administration (FDA). The lawsuit also alleges that implantation of the device left Mrs. Vialpando with “permanent injuries and a lack of mobility,” said the LV Business Press. “Stryker knew or should have known that its pain pumps, when used with aesthetic medications in the joint space, could be toxic to shoulder cartilage,” the court filing states. More Shoulder Pain Pump Lawsuit Filed In Nevada

Sybaritic Inc., a medical device maker, has agreed to stop producing and distributing its unapproved devices used in laser surgery, dermatology, and spa treatments until it is in compliance with U.S. Food and Drug Administration (FDA) quality standards, the agency just announced. The products are considered to be unapproved medical devices because they lack appropriate FDA clearance review and approval for safety and efficacy.

The agreement was part of a consent decree of injunction signed by Bloomington, Minnesota, company and three of its top executives, Anthony S. Daffer, Steven J. Daffer, and Ronald Berglund. “This action halts the manufacture of these products until the manufacturer comes into compliance with federal law,” said Jeffrey Shuren, M.D., J.D., acting director of the FDA’s Center for Devices and Radiological Health. “It’s critical that companies comply with laws that are in place to protect consumer health.” More Firm Agrees To Stop Selling Unapproved Medical Devices