The most hazardous level assigned to a defective and dangerous product by the Food and Drug Administration is a Class 1 Recall. The FDA assigns Class 1 recalls when a product is likely to cause serious illness or death.
On May 18, 2009 the FDA announced a Class 1 recall on certain Medtronic pacemakers because there is a high risk of failure due to a separation of wires that connect the electronic circuit to other parts of the pacemaker, such as the battery. For patients who depend on pacemakers for the regulation of a normal heart beat, pacemaker failure could lead to serious complications.
Legal Help is Available
If you fear that you could be potentially sustain an injury, or already have, by your Medtronic pacemaker, always consult your physician as soon as possible. If you have been injured by one of these devices, you are probably faced with costly medical bills that are a result of a manufacturer's negligence.
Our legal team, who are also working with attorneys in Canada, are here to help you understand your legal rights, and to also help you make a recovery for your injury, which includes the trauma of having this device replaced.We understand the global economic difficulties and how costly medical bills are overwhelming victims. That is why our legal team works on a contingency fee basis. Unless we make a recovery for you, you will not owe us any attorney's fees.
FDA Issues Class 1 Medtronic Pacemaker Recall
In May of 2009, Medtronic announced a recall of certain Kappa 600/700/900 and Sigma 100/200/300 series pacemakers. In June 2009, the FDA classified this recall as a Class 1 recall. The Food and Drug Administration has reserved Class 1 recalls for dangerous or defective products that are reasonably likely to cause serious injury or death. Health Canada also issued an advisory on May 18, 2009.
The Danger of this Product
The defect prompting this recall relates to the potential that wires connecting the electrical circuits may separate from other components, such as the battery, resulting in:
- loss of pacing output
- loss of telemetry
- or premature battery depletion
In late May 2009, Medtronic sent letters to patients with these recalled pacemakers warning of this potential danger. Medtronic has advised patients with these recalled pacemakers, particularly if they are pacemaker-dependent, as well as their health care providers, to consider replacing these defective pacemakers. At the time of the recall, Medtronic was aware of over 400 failures in the recalled pacemaker series, and had projected failure rates close to 5%, while acknowledging that reported failure rates for these devices generally underestimate actual failure risks. Of particular concern are the facts that no testing can predict which devices will fail, and no device programming can undo failures once they occur.
Health Canada Responds to the Medtronic Pacemaker Defect
Medtronic estimated that over 22,000 of these defective pacemakers are still in use world-wide, 3,200 of which remain implanted in Canadian patients.
Health Canada sent out an "Important Patient Safety Information" letter to Health Care Professionals who have patients with these defective devices, and may be at risk of serious injury.
Immediate Legal Investigations
If you have one of these defective, recalled pacemakers, and reside in Canada, we are working attorneys in Canada to assist you in obtaining fair compensation for any injuries you may have had, including compensation for the trauma of having to undergo an operation to explant and replace this device.
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