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Event Summary  
Event Type Medicine - Medical Products Or Devices  Date Time 2022-04-27 20:29:00 
Country US  City Silver Spring, MD 
Latitude 38.991  Longitude -77.026 
URL https://www.dicardiology.com/content/medtronic-recalls-harmony-delivery-catheter-part-tpv-system-risk-capsule-break-during-use     

[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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