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

FDA device recall Z-0927-2022 · posted 2022-04-18 · Open, Classified

Recall details

Recalling firm

Medtronic Inc

Reason for recall

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

Action taken

Beginning 02-MAR-2022 Medtronic initiated communications of an Urgent Medical Device Notice letter via 2-day UPS delivery to consignees who have received affected product according to Medtronic records. Consignees are asked to review the Medtronic Urgent Medical Device Notice notification and follow the Recommended Actions. Implanting physicians associated with related valves to the Harmony DCS were included in notifications, though these valve products are not subject to the recall issue. Additional verbal communication was initiated for a full product recall on March 24. Written communications were mailed on April 5, 2022 stating that Medtronic is recommending an immediate suspension of the Harmony DCS product use and is undertaking a voluntarily recall of the Harmony DCS.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

NPV

Quantity affected

1483 devices

Distribution

US Nationwide and the countries of Canada.

Date initiated

2022-03-02

Date posted

2022-04-18

Location

Minneapolis, MN