Dangerous Medical Device Recalls – Medtronic and the FDA

Medtronic, the medical device manufacturer, has had many of its medical products subject to a flurry of Class I recalls and warnings in recent months. These include Medtronic catheters, defibrillators, and pacemakers being issued the FDA most severe warnings for defects that may cause potentially severe injuries.

Medtronic’s Sutureless Connector intrathecal catheters (SC catheters) were recalled for labeling errors that have already negatively affected 10 patients when, per company instructions, the catheter was used with the Medtronic IsoMed Pump Model 8472, a constant-flow infusion drug pump Medtronic discontinued last year as part of a “planned product phase-out.” What some might see as a minor oversight in printing–unless you’re one of the nine patients depending on the pumps’ cancer-fighting drugs whose catheters became disconnected and who required surgery to correct the problem, especially if you’re one of the nine who died two days following the procedure.

The IsoMed pump, approved by the FDA to deliver anti-cancer drugs directly to the liver to prevent the spread of colon cancer, will continue to operate with the non-compatible catheter. This gives the impression of delivering treatment, as designed, when it is in fact leaking this needed treatment into surrounding tissues. This leakage can cause drug overdoses and tissue damage. Medtronic urges doctors to use their best judgment as to whether intrusive surgery is needed to correct their defective products’ potentially life-threatening problem.

Catheter Models 8709SC, 8731SC, 8578, and 8596SC are affected by the FDA recall.

Some Medtronic LifePak CR Automated External Defibrillators (AED) are also being recalled because they may not function properly, or at all, in humid conditions. Another Class I FDA recall, this one covers defibrillators made by Medtronic’s Physio-Control division and distributed between 7/9/2008 and 8/19/ 2008. The FDA issues Class I recalls only when there is potential for serious or fatal injury from use of a particular device or product, and this is no exception for this Medtronic medical device. FDA officials have found that the LifePak CR units, intended to deliver electric shocks to fix abnormal heart rhythms, fail to analyze heart rhythms correctly in humid conditions. Shocks to restore normal heart rhythms may be delivered incorrectly or not at all.

Also defective, Medtronic’s Concerto CRT-D and Virtuoso ICD pacemakers whose batteries die sooner than their expected date. An estimated 6,300 are affected. An additional 37,000 Medtronic Kappa and Sigma pacemakers may have a wiring defect that can cause malfunction. Medtronic’s solution has been to warn doctors whose patients have an affected pacemakers to seek “medical attention immediately if they experience fainting or lightheadedness.”

FDA Commissioner Margaret Hamburg has said that she will address discontent in the FDA’s medical device division and its complaints that the nearly $200 billion medical-device industry operates under approval standards that puts Americans’ health at risk. The Government Accountability Office has reported that from 2003 to 2007 the FDA approved 228 medical devices without full safety and effectiveness evaluation. Over 20,000 companies manufacture medical devices, and each pressures regulatory agencies to get their products on market ASAP. Once available, medical device companies will hard sell their products, sometimes regardless of their product’s safety and efficacy. At the end of the day, the equipment being sold isn’t a medical device to its manufacturer, it’s a money-making machine.

If a defective medical device has caused you or a loved one injury, contact Higgins Firm to explore your legal options with a defective medical device lawyer. Call 1.800.705.2121 or fill out our defective medical device injury form. Our Nashville, TN law offices accept cases throughout Tennessee and select cases in Georgia and Kentucky.

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