FDA Medical Device Recalls (openFDA)
Medtronic Inc: Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
- Recall number
- Z-0927-2022
- Recalling firm
- Medtronic Inc
- Product
- Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
- Status
- Open, Classified
- Initiated
- 2022-03-02
- Posted
- 2022-04-18
- Terminated
- not on file
- Reason
- There is potential for the capsule bond to break during the procedure.
- Root cause
- Under Investigation by 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.
- Quantity
- 1483 devices
- Distribution
- US Nationwide and the countries of Canada.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P200046"]
- Product code
- NPV
- Firm FEI
- 3001504994
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28