Federal health officials have toughened an already-announced recall of guidewires made by Medtronic, saying that the problems are serious enough to cause serious injury or death.The warning covers about 15,000 recalled guidewires, which are used in various heart procedures. A recall of the guidewires began Oct. 21 after Medtronic received reports of four complaints, including one patient who went into cardiac arrest but was resuscitated. The recall notice warned hospitals and distributors worldwide that coating on the guidewires could break off, causing obstructions or clots. The wires are coated to make them slide through blood vessels more easily. Medtronic announced Friday night that the Food and Drug Administration had classified the recall as Class I, a category reserved for products with reasonable potential to cause serious injury or death. The company said it has taken steps to prevent new shipments of the wires. It also has notified regulators around the world.
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Problems with the guide wires can be reported to Medtronic by calling 877-526-7890 during weekdays from 8 a.m. to 5 p.m. CT; adverse reactions or quality problems can be reported to the FDA.