The procedure to implant a cardiac stent, which keeps blocked arteries open, includes inserting guidewires to move the device into place. Federal health officials have issued a warning about a defect in some Medtronic guidewires that might cause serious injury, or even death.
The FDA classified the company’s Oct. 21 recall as Class I. That category is for products officials say have the potential to cause the most serious harmful effects. About 15,000 guidewires are involved.
Hospital and medical device distributors were warned that the coating on the wires could break off, reported USA Today, and possibly block a blood vessel. The coating is supposed to make the wires slide through blood vessels more easily.
If you have a cardiac stent procedure planned, make sure your doctor and hospital are aware of the recall for devices manufactured between April and September, and distributed through October. Make sure they’ve read the alert, and ask if any of their patients experienced problems (if, for no other reason, to focus their attention on the models of concern, listed in the FDA document).
If you have questions, call Medtronic at (877) 526-7890.