—#192430

Product

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

FDA product code: NPV — Pulmonary Valve Prosthesis Percutaneously Delivered
Device class: Class f
Medical specialty: Unknown
PMA numbers: P200046
Affected lot / code info: HARMONY-DCS (GTIN: 00763000341367); Lot Numbers: 0010519040, 0010565921, 0010578123, 0010578126, 0010583884, 0010631963, 0010631969, 0010631971, 0010717000, 0010717001, 0010717002, 0010723188, 0010723189, 0010723190, 0010727345, 0010804938, 0010826589, (the following lots were added 4/22/2022) 0010826591, 0010826592, and 0010826593

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Medtronic Inc
Address: 710 Medtronic Pkwy, Mailstop Ls245, Minneapolis, Minnesota 55432-5603

Distribution

Distribution pattern: US Nationwide and the countries of Canada.

Timeline

Recall initiated: 2022-03-02
Posted by FDA: 2022-04-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #192430. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.