FDA recall Z-0927-2022

Medtronic Inc · Class I · device

Product

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

Reason for recall

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

Distribution

US Nationwide and the countries of Canada.

Key facts

Status
Ongoing
Initiation date
2022-03-02
Report date
2022-04-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0927-2022