Sunday, November 17, 2013

FDA issues stern warning on Medtronic devices

http://www.nbcnews.com/health/fda-issues-stern-warning-medtronic-devices-2D11603309


DAVID KOENIG, The Associated Press East Valley Tribune
Nov. 16, 2013

Federal health officials say that defects in some Medtronic devices used in heart procedures are severe enough that they could cause serious injury or death.

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.

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