FDA-Device2022-04-27Class I
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
Medtronic Inc
Hazard
There is potential for the capsule bond to break during the procedure.
Sold states
US Nationwide and the countries of Canada.
Affected count
1483 devices
Manufactured in
710 Medtronic Pkwy Mailstop Ls245, Minneapolis, MN, United States
Products
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0927-2022Don't want to check this manually?
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