FDA issues stern warning on Medtronic devices
Source: AP-Excite
By DAVID KOENIG
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.
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.
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Read more: http://apnews.excite.com/article/20131117/DAA40SHO2.html
In this Aug. 16, 2005 file photo, The "Rising Man" symbol stands in front of the Fridley, Minn., based Medtronic. Medtronic announced Friday, Nov. 15, 2013, that the Food and Drug Administration recall of 15,000 guidewires had been classified as Class I, a category reserved for products with reasonable potential to cause serious injury or death. (AP Photo/Jim Mone)
WheelWalker
(8,955 posts)AllyCat
(16,189 posts)an implantable pump that didn't work.
madrchsod
(58,162 posts)i have a medtronic deflator in my chest. so far so good!
Thor_MN
(11,843 posts)I didn't know Medtronic made a device for excessive gas...
I think you mean Defibrillator?