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Open, Classified

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

FDA Recall Z-0927-2022 · Posted 2022-04-18

Recalling FirmMedtronic Inc
Recall StatusOpen, Classified
Product CodeNPV
Date Initiated2022-03-02
Product Quantity1483 devices

Reason for Recall

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

Firm Action

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

Distribution Pattern

US Nationwide and the countries of Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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