Recall Of Medtronic Guidewire High-Risk Class I, FDA Says

Medtronic’s Angiographic Guidewire Component, distributed since 2007, was recalled because the devices weren’t sterilized. It’s the company’s eighth class I recall this year.

The Medtronic logo is seen on an LED screen in the background while a silhouetted person uses a smartphone in the foreground.

The US Food and Drug Administration says a recall by Medtronic PLC of its Angiographic Guidewire Component devices is high-risk class I.

The company’s vascular division recalled nearly 55,000 of the guidewires on 4 May; they were distributed from November 2007 through March 2021.

More from Recalls

California Medtech Firms Resolve Patent Dispute Over Delivery Catheters

 

Route 92 says it has reached a settlement with Q’Apel Medical over patent claims concerning its Tenzing delivery catheters.

Q’Apel Medical Recalls, Discontinues Stroke Therapy System After FDA Warning Letter, Class I Designation

 

Q’Apel Medical has pulled its aspiration system for stroke thrombectomy from the market after concerns raised by the US FDA in a February warning letter.

Makary Proposes Combined Adverse Event Reporting Systems In Megyn Kelly Interview

 

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.

FDA Issues A Pair Of Early Alerts For Intravascular Catheters

 

The US FDA continues to issue early alerts as part of its communications pilot aimed at improving how the agency manages recalls. This time, the agency is notifying users about two separate intravascular catheters.

More from Policy & Regulation