The warning covers about 15,000 recalled
guidewires, which are inserted through an artery and used to
guide other devices into place, such as stents to hold open
blocked arteries.
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, company spokesman
Joseph McGrath said Saturday.
The recall notice warned hospitals and distributors worldwide
that coating on the guidewires could break off, which could
raise the possibility of blocking a blood vessel. 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 Minneapolis company said the recall affected certain lots
made since April. The company said it has taken steps to prevent
new shipments of the wires. It also has notified regulators
around the world.
___
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. CST;
adverse reactions or quality problems can be reported to the FDA
at
http://www.fda.gov/Safety/MedWatch/
HowToReport/default.htm.
[Associated
Press; DAVID KOENIG]
Copyright 2013 The Associated
Press. All rights reserved. This material may not be published,
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