FDA Device recall Z-0927-2022
Harmony Delivery Catheter System
- FDA Device
- Class I
- ongoing
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class I recall of Harmony Delivery Catheter System by Medtronic, citing there is potential for the capsule bond to break during the procedure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0927-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-03-02 |
| Published | 2022-04-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic |
| Distribution | US |
Product
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
Reason
There is potential for the capsule bond to break during the procedure.
Identifiers
| code_info | HARMONY-DCS (GTIN: 00763000341367); Lot Numbers: 0010519040, 0010565921, 0010578123, 0010578126, 0010583884, 001063196…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0927-2022%22
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