Harmony recallZ-0927-2022 · Medtronic Inc · initiated Mar 2, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is potential for the capsule bond to break during the procedure.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0927-2022
- Status
- Open, Classified
- Initiated by the company
- Mar 2, 2022
- Posted by the FDA
- Apr 18, 2022
- Recalling firm
- Medtronic Inc
- Quantity
- 1483 devices
- Product code
- NPV
- FDA submissions
- P200046
- Distribution
- US Nationwide and the countries of Canada.
Product description
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Harmony™ HARMONY-DCSMedtronic, Inc. · Pulmonary valve prosthesis percutaneously delivered2 recalls35 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under P200046 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Harmony™ HARMONY-25Medtronic, Inc. · Pulmonary valve prosthesis percutaneously delivered3 deaths151 reports
- Harmony™ HARMONY-22Medtronic, Inc. · Pulmonary valve prosthesis percutaneously delivered8 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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