Defects in some Medtronic devices used in heart procedures are severe enough to cause serious injury or death, according to federal health officials.
About 15,000 guidewires that are inserted through an artery to guide other devices, such as stents to hold open blocked arteries, into place have been recalled since October. Medtronic received reports of four complaints, including one patient who went into cardiac arrest.
The recall notice warned hospitals and distributors that the coating used on the wires to make them slide through blood vessels more easily could break off, which could raise the possibility of blocking a blood vessel.
The Food and Drug Administration has classified the recall as Class I, a category reserved for products with reasonable potential to cause serious injury or death. Read the full details here:
FDA issues stern warning on Medtronic devices
If you or a loved one is scheduled to undergo surgery, ask whether a guidewire is going to be used. If so, inquire as to whether any recalls for that wire exist.
If you have been injured due to medical malpractice, including faulty medical devices, please call to investigate your matter fully. Crandall & Pera Law is available to help answer your questions and guide you in determining your next steps.