Z-0927-2022Class I

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

Name: Z-0927-2022 Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement...
Creator: Medtronic Inc
Published: 2022-03-02
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2022-03-02 / Open, Classified

FDA source

Medtronic Inc began a recall of Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System on 2022-03-02. FDA classified it as Class I and gives the reason as "There is potential for the capsule bond to break during the procedure". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0927-2022
Classification: Class I
Status: Open, Classified
Initiated: 2022-03-02
Posted: 2022-04-18
Recalling firm: Medtronic, Inc.
Product: Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
Product code: NPV Pulmonary Valve Prosthesis Percutaneously Delivered
Reason for recall: There is potential for the capsule bond to break during the procedure.
FDA 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 in commerce: 1483 devices
Distribution: US Nationwide and the countries of Canada.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0927-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0927-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-18

Product code NPV

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)