FDA issues stern warning on Medtronic devices
David Koenig, AP Business Writer 7:34 p.m. EST November 16, 2013
Defects in some guidewires for hearts are severe enough to cause injury or death, agency says.
The “Rising Man” symbol stands in front of the Fridley, Minn.-based Medtronic. (Photo: Jim Mone, AP)
- Warning covers about 15,000 recalled guidewires used in heart procedures
- Recall began Oct. 21, after Medtronic received reports of four serious complaints
- Government is offering help at a toll-free hotline and on the FDA website
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.
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.