Medtronic Inc recalls Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation Syst

Recalled April 27, 2022 · FDA recall Z-0927-2022 · Medtronic

Hazard

There is potential for the capsule bond to break during the procedure. · FDA Class I

Units

1483 devices

Sold at

US Nationwide and the countries of Canada.

Description

There is potential for the capsule bond to break during the procedure.

Product

Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.

Manufacturer(s)

Medtronic Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →