FDA confirms Class I recall of Medtronic Harmony delivery catheters
The Food and Drug Administration has classified Medtronic’s recall of certain Harmony Delivery Catheter System lots as Class I, its most serious medical-device recall category. The affected catheter may have an increased risk that its distal tip detaches during a procedure to implant the Harmony transcatheter pulmonary valve.
The recall does not involve the implanted Harmony pulmonary valve itself. Patients who already had a Harmony valve successfully implanted generally do not need recall-specific action and should continue routine follow-up with their clinical team.
What changed
Medtronic initiated the recall on May 22, 2026, and the FDA posted the Class I classification on July 2, 2026, under recall number Z-2624-2026. The FDA record lists the recall as open and classified. The agency’s database page was last updated July 31, 2026.
A Class I designation means continued use of the affected device could cause serious injury or death. It does not mean every device failed or that every patient was harmed.
Which device is involved
The recalled product is the Medtronic Harmony Delivery Catheter System, model HARMONY-DCS. It is a single-use catheter used in a catheterization lab to position and deliver the Harmony transcatheter pulmonary valve.
The recall applies only to specified lots and device identifiers. FDA records list 1,881 units in commerce and four affected UDI-DIs, with nationwide U.S. distribution as part of worldwide distribution. Hospitals and patients should use the FDA’s official recall record to check the full lot and UDI list rather than assume every Harmony catheter is affected.
Why the FDA acted
Medtronic reported that inner-shaft assemblies from certain manufacturing lots may have an increased potential for distal-tip detachment under certain procedural or anatomical conditions. The FDA record identifies a manufacturing issue and lists process control as the agency’s determined cause category.
If the tip detaches while the valve is being delivered, a secondary intervention may be needed to remove it. That could involve endovascular retrieval or surgery. The FDA also lists possible risks including a longer procedure, extended fluoroscopy exposure, occlusion, tissue damage, pulmonary regurgitation, embolism and hemorrhage.
As of May 14, 2026, Medtronic had not reported serious injuries or deaths associated with the issue. That cutoff does not guarantee that later reports will not be added as the open recall record develops.
What hospitals must do
Medtronic’s May 28 customer notice instructed facilities to review inventory, immediately quarantine affected units and arrange their return. Hospitals were also told to share the notice with implanting physicians and their teams, notify other facilities if products had been forwarded, and complete the company’s confirmation paperwork even if no affected units remained on site.
Facilities should compare their inventory with the FDA’s lot and UDI information and contact Medtronic through the recall process for return, exchange or credit instructions.
What patients should know
The risk described in the recall occurs during delivery of the valve through the affected catheter. It is not a warning that an implanted Harmony valve must be removed or replaced.
Patients with an upcoming or recent procedure who have questions should ask the implanting hospital whether the catheter used, or planned for use, came from an affected lot. Individual care questions should be directed to the treating cardiology or structural-heart team, which can review the patient’s procedure record and clinical circumstances.
The FDA says the recall remains open and may be updated. Patients and clinicians should rely on the agency’s current recall record and their medical team for lot-specific or personal medical guidance.
Sources
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