[dicardiology.com] MARYLAND - Medtronic Recalls Harmony Delivery Catheter - Part Of TPV System - For Risk Of Capsule Break During Use

"The U.S. Food and Drug Administration (FDA) has issued a Class I recall for the Medtronic Harmony delivery catheter, part of the transcatheter pulmonary valve (TPV) system, for risk of capsule break during use. Use of these devices may cause serious injuries or death, according to the FDA's statement."

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https://www.dicardiology.com/content/medtronic-recalls-harmony-delivery-catheter-part-tpv-system-risk-capsule-break-during-use