FDA: Medtronic Issues Recall of Harmony Delivery Catheter

Medtronic is recalling its Harmony Delivery Catheter as there is a risk the bond holding the capsule at the end of the delivery catheter may break during a procedure to place the Transcatheter Pulmonary Valve (TPV) System, the Food & Drug Adminstration says in a statement.

• Recall was initiated by the company on March 2, 2022
• FDA says there have been 6 reported complaints from clinical cases, one injury, and no deaths associated with the use of these devices
• Medtronic shares are down 0.9%

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Sebastian Tong in San Francisco at stong41@bloomberg.net

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