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

FDA enforcement event 89754 · Class I · initiated 2 Mar 2022 · status Ongoing

DeviceVoluntary: Firm initiated1 product recordMinneapolis, MN

Medtronic Inc (Minneapolis, MN) initiated this device recall on 2 Mar 2022; FDA lists 1 product record under event 89754, classified Class I.

FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 8% of the 839 device enforcement events initiated in 2022 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Medtronic Inc has 47 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Medtronic Inc, Minneapolis, MN.

Reason for recall

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

Distribution

"US Nationwide and the countries of Canada."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0927-2022	Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.	1483 devices	Class I	Ongoing	27 Apr 2022

Context

8%of 2022 device events are Class I839 events that year

1product record in this eventfirm median: 1

47events on this register for the firm

Other enforcement events for Medtronic Inc

Initiated	Product (first record)	Type	Class	Records
11 Mar 2026	Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial f	Device	Class II	1
4 Dec 2025	Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090	Device	Class II	1
29 Oct 2025	Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product	Device	Class II	1
18 Jun 2025	Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Cro	Device	Class II	2
17 Jun 2025	Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software compo	Device	Class II	2
29 Apr 2025	Azure S DR MRI SureScan, Product number W3DR01	Device	Class II	1
11 Jul 2024	2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE	Device	Class II	1
16 Apr 2024	COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator	Device	Class II	23
16 Feb 2024	Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090	Device	Class II	1
7 Dec 2023	Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1	Device	Class II	1

All 47 events for Medtronic Inc

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "There is potential for the capsule bond to break during the procedure."

What does Class I mean?

FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide and the countries of Canada."

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.