FDA recalls Medtronic guidewires: says they could be fatal


The Associated Press reports the Food and Drug Administration is recalling Medtronic guidewires used in heart surgery.

The FDA website shows the recall notice to hospitals and distributors was issued Friday. It says coatings of tiny wires used in heart operations have the potential to "detach or delaminate." It is a Class I recall, which is reserved for products that could cause serious injury or death.

In a news release, the Minneapolis-based company said it had stopped shipment of the guidewires and notified hospitals and regulators worldwide that products in the field should be quarantined. It says the company began recalling the devices in late October, after it received four complaints, including one about a patient who went into cardiac arrest but was resuscitated.

The company statement said the products were made after mid-April. It has more details about which specific lots and product lines are affected.

In June, the FDA also issued a Class I recall for a Medtronic implantable drug pump that the company said was responsible for the deaths of 14 patients.

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