Medtronic Recalls Harmony Delivery Catheter as Capsule May Separate

U.S. Food and Drug Administration sent this bulletin at 04/26/2022 11:06 AM EDT

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CDRH Medical Device Recall

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Medtronic Recalls Harmony Delivery Catheter, Part of Harmony Transcatheter Pulmonary Valve (TPV) System, for Risk of Capsule Break During Use

Medtronic is recalling the Harmony Delivery Catheter because it is possible that the bond holding the capsule at the end of the delivery catheter may break during a procedure to place the TPV. A capsule bond break during use could cause procedure delays, the need for additional procedures, or serious harm to the patient’s blood vessels.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.

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Questions?

If you have questions about this recall, contact Medtronic Customer Service at 800-854-3570.