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Recall Of Medtronic Delivery Catheters Given Class I Designation

 
• By Shawn M. Schmitt

The US FDA gave its highest risk classification to a recall of Medtronic’s Harmony Delivery Catheter. This is the second high-profile recall action that the device giant has racked up this year related to catheters.

Sign of Medtronic at Canada Headquarters in Brampton, Ontario, Canada.
• Source: Shutterstock

A recall by Medtronic PLC of its Harmony Delivery Catheter has been given a high-risk class I designation by the US Food and Drug Administration.

The catheter, part of the Transcatheter Pulmonary Valve (TPV) System, was recalled because “the bond holding the capsule at the...

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