US FDA warns Medtronic's recalled guidewires could cause death

The US health regulator warned over the weekend that defects in the 15,000 recalled guidewires used in heart procedures made by Medtronic Inc could cause serious injury, or even death.

The US Food and Drug Administration (FDA) has classified certain lots of the company's recently recalled defective guidewires made since April as a Class I recall, a category reserved for products or devices that has the potential to cause serious injury or death.

On 21 October,  Medtronic recalled around 15,000 guidewires worldwide after it received four complaints, including one of a patient who had to be resuscitated after a cardiac arrest.

The Minneapolis-based company said that based on an internal investigation following a limited number of complaints, including one patient injury, it began notifying hospitals and distributors worldwide that the coating on the surface of some models of its guidewires from recent lots have the potential to delaminate and detach.

Medtronic's notification requested that all potentially affected units be quarantined immediately and returned to the company as soon as possible for credit and replacement.

Guidewires are inserted through an artery and help doctors to put other devices like stents into place which opens blocked arteries.

The coating on Medtronic's Guidewires could come off, leading to blood clots or other problems.

The guidewires covered by the recall are:

1.       Cougar steerable guidewire

2.       Zinger stainless steel workhorse guidewire

3.       Zinger steerable guidewire

4.       Thunder extra-support guidewire

5.       Thunder steerable guidewire

6.       ProVia crossing guidewire

7.       Attain Hybrid guide wire

Medtronic, the world's largest independent medical products maker, also sells most of these recalled devices in India through its local subsidiary.