Health officials from the federal government have reported that defective surgical devices manufactured by Medtronic are causing severe problems in patients who are implanted with the devices. The problems can be so detrimental that patients with the implantations are at risk for serious health problems and even death.
The Food and Drug Administration's warning encompasses nearly 15,000 recalled "Guidewire" products. A Guidewire is an instrument that is inserted into an artery that guides other medical devices, such as blocked artery opening stents, into place.
The first recall of the Medtronic Guidewire was issued on October 21, 2013 after the company received four separate complaints, including one instance where a patient went into cardiac arrest, but was resuscitated. It is still unclear which of the four are most dangerous, or if they are all equally fallible. The four types of Medtronic Guidewires in question are the Cougar Guidewire, Persuader Guidewire, Thunder Guidewire, and Zinger Guidewire.
The FDA's recall notice including a warning to physicians, surgeons, distributors, and hospitals globally, stating that the Silicone and/or Hydrophilic coating, used to allow the component to glide more smoothly through the body, could potentially break off and cause a blockage in the blood vessels.
Last Friday, the FDA classified the Medtronic Guidelines recall as a Class 1. Class 1 recalls are designated for defective products that have serious potential to cause detrimental injuries and even death.
Medtronic, a Minneapolis-based medical device manufacturer has admitted that the current recall will be affecting batches of Guidelines that were developed as far back as April 2013. Medtronic claims that they are now preventing shipments of the Guidewires overseas and have made formal announcements to customers across the globe.
If you think that you have been injured by a Medtronic Guideline, then you can report the issue to Medtronic by calling 877-526-7890, weekdays from 8 a.m. to 5 p.m. central standard time. For further assistance involving adverse responses to a recent surgery then please contact the FDA at www.fda.gov/Safety/MedWatch/HowToReport/default.htm.
Source: USA Today, "FDA issues stern warning on Medtronic devices" 16 November 2013