Skip to main content

FDA recalls Medtronic guidewires: says they could be fatal

  • Author:
  • Updated:
    Original:

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.

Next Up

Doug Pederson

5 names floating around in the NFL head coaching market

Who will the Vikings hire to replace Mike Zimmer?

distance learning

Osseo district moves to distance learning; 'extremely high number' of absences

Some schools are down 25% of their staff due to illnesses.

Mike Zimmer

Mike Zimmer offers statement after being fired by Vikings

Zimmer was fired on Monday after eight seasons with the Vikings.

2006 Chevrolet Suburban

Footprints near stuck SUV lead deputies to body of missing WI man

The 30-year-old had disappeared nearly a week ago.

Eric Kendricks

Vikings' Kendricks says 'fear-based' approach not the way to go

The linebacker spoke to the media Monday after Mike Zimmer's firing.

tony webster light rail green line flickr

Man charged in light rail knife attack and police squad arson

The separate incidents happened days apart, with the suspect now charged in both cases.

covid test 5

Biden Admin: Home COVID tests will soon be covered by insurance

The tests will be free with insurance starting Saturday.

chaska 3

Historic home in downtown Chaska on the market for $430,000

The property is zoned commercial and residential.

Kirk Cousins

Vikings owner on Cousins situation: 'It's not a simple answer on all this'

The high-profile quarterback has a $45 million cap hit next season.

duluth fire 2

Duluth firefighters battling blaze at former Seaway Hotel

Wind chills were 35 below zero Monday morning.

Mike Zimmer

Coller: Mike Zimmer set the bar high and then couldn't reach it

The head coach whose teams were known for their fight went out in back-to-back seasons in meaningless games. Few coaches survive that.

Rick Spielman

Rick Spielman issues statement after being fired by Vikings

Spielman was let go by the franchise he had called home for 16 years.

Related