Defective Medical Devices

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Medtronic Pacemakers

Medtronic Inc. announced they are advising physicians of a potential problem in a small number of its Sigma pacemakers in which wires may separate from a circuit. No deaths or injuries were reported, though some users suffered dizziness or fainting, according to the Fridley-based medical-devices maker. An estimated 28,000 pacemakers, including 6,650 in the U.S., are covered by the advisory, with Medtronic said could be classified by the U.S. Food and Drug Administration as a recall.

Medtronic said the defect took place when a solvent used to clean pacemaker wires degraded them over time, causing the wires to break from the circuitry in 19 devices. Pacemakers help spark the heart to achieve a steady, timely beat. The company estimates that 47 to 84 units, all made between November 2001 and August 2004, could be affected over the 10 year life of the units.

"The risk of patients is extremely low, but we are alerting physicians to the issue to ensure they are aware of the situation and can approximately care for their patients", said Steve Mahle, president of Medtronic's cardiac rhythm management division.

Although the company doesn't recommend replacing the devices "prior to normal elective replacement", it added that this decision should be left up to the doctor based on each patients unique circumstances.

If you or a loved one suffered injuries from a Medtronic Pacemaker, please fill out the form at the bottom of this page for a free lawsuit case evaluation by a qualified defective medical device attorney.

Medtronic reports pacemaker defect
November 30, 2005 - Medtronic reports pacemaker defect Medtronic Inc., the world's biggest maker of electronic heart devices, said Tuesday it is notifying doctors about a potential defect in some of its Sigma series pacemakers. No deaths or injures were reported, though some users suffered dizziness or fainting, according to the Fridley-based.

Medtronic Says Some Pacemakers Have Faulty Wires
November 29, 2005 - Medtronic Says Some Pacemakers Have Faulty Wires Medtronic Inc. said on Tuesday it is advising physicians of a potential problem in a small number of its Sigma pacemakers in which wires may separate from a circuit. The Minneapolis-based medical device maker said the overall incidence rate is "extremely low" and there have been no reports.

Introduction: Guidant Recall
Guidant Corporation, headquartered in Indianapolis, Indiana, is the second-largest manufacturer of implantable defibrillators and also manufactures pacemakers, cardiac surgery systems, and other medical devices.

Our firm, Lieff Cabraser Heimann & Bernstein, LLP<, is representing Guidant patients across the U.S. in personal injury lawsuits seeking damages for the injures they suffered due to Guidan't alleged negligence. WE filed the first lawsuit in the nation against Guidant for its defective defibrillators, and are representing scores of Guidant patients with faulty heart devices.

Guidant Defibrillator Recall
On June 17, 2005, Guidant announced a recall of nearly 50,000 heart defibrillator devices. Guidant expanded the recall on June 24, 2005, when the company announced additional 46,000 devices were potentially defective. Implantable defibrillator systems detect and treat abnormally fast hear rhythms that could result in sudden cardiac deaths.

As of October 2005, Guidant reported it was aware of over 50 reports of device including three cases in which the patients died. Guidant has acknowledged that the failure may be higher than the reported rate and that the number of associates deaths underreported, since implantable cardio-defibrillators are not routinely evaluated.

Guidant Pacemaker Warnings
On September 22, 2005, Guidant issued a recall for some of its Insignia and Nexus implantable pacemakers because of failures, including nine cases requiring emergency hospitalization.

On July 18, 2005, Guidant alerted physicians that replacements might be needed for nine pacemaker models made between 1997 and 2000, of which some 28,000 remain implanted in patients worldwide.

Guidant Ancure Endograft system Recall
In June 2003, Endo Vascular Technologies (EVT), a subsidiary of Guidant, pleaded guilty to 10 felony counts and agreed to pay $92.4 million in civil and criminal penalties related to its Ancure Endograft system, a stent-graft device inserted by means of a catheter for the treatment of abdominal aortic aneurysms.

EVT admitted that it had lied to the government and hidden thousands of malfunctions with the Ancure Endograft, including 12 patient deaths. The company stopped selling the system in March 2001, made changes and reintroduced it to the market in August 2001.

Guidant Defibrillators Recalled
On June 17, 2005, Guidant recalled more than 50,000 of its cardiac defibrillators patients because of potential malfunctions in the devices. The recall includes the Venta (model 1861), Contak Renewal (model H135) and Contak Renewal 2 (model H155), V AVT, Vitality AVT, Renewal AVT, Contak Renewal 3 and 4, Renewal 3 and 4 AVT and Guidant said it has determined that a magnetic switch in these devices may get stuck in position, which in some cases inhibits their ability to treat ventricular or atrial tachyarrythmia can accelerate battery depletion.

The suspension affects 46,000 of these devices, Guidant said, without specifying how many have been surgically implanted in people's chests and how many may be on supply shelves.

Patient Injures and Deaths
As of June 2005, Guidant admitted that it was aware of 43 reports of device failures and two patient deaths. Guidant has acknowledged that the actual rate of failure may be higher that the reported rate and that the number of associated deaths may be underreported, since implantable cardio-defibrillators are not routinely evaluated after death. The FDA and Guidant have advised physicians and patients to make individual decisions about whether to remove and replace the affected defibrillators on the basis of the specific medical situation of the patient.

Defective Medical Devises
Defective Medical devices can cause serious injures and are complex legal cases. Our lawyers have the experience and resources to handle these, complex cases. While you are learning more about your legal rights, please remember that our law firm offers free, no obligation legal consultations to determine if you may have a legal case for your injury.

Heart Defibrillators
Guidant Corporation recalled 50,000 heart devices after reports of electrical failures and deaths. The implanted devices are supposed to deliver a life-saving shock to patients with irregular heart rhythms.

Infusion Pumps
Baxter Healthcare Corp. recalled 206,000 infusion pumps after reports of deaths and serious injury. The infusion pumps can shut down while delivering critical medication and fluids to patients.

Bronchoscopes
Bronchoscopes are used to inspect the lungs. Some bronchoscopes may be defective and may be spreading bacteria.

Heart Stents
Boston Scientific has recalled some designs of heart stents. The delivery catheters in the recalled systems may be flawed. During a procedure, the balloon may fail to deflate. This failure can hinder the removal of the balloon after the stent is placed.