FDA issues stern warning on Medtronic devices - 13 WTHR Indianapolis

FDA issues stern warning on Medtronic devices

Updated:

Federal health officials say 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 company spokesman says the recall began October 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, which could raise the possibility of blocking a blood vessel.

Medtronic says the recall affects certain lots made since April. The Minneapolis company says it has taken steps to prevent new shipments of the wires. It also has notified regulators around the world.

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