Agency classClass IOur severity:Severe FDA (Devices)·Z-2624-2026·Announced 2026-07-08

Medtronic Harmony Delivery Catheter System Distal Tip Detachment Risk

Medtronic is recalling certain lots of the Harmony Delivery Catheter System due to a manufacturing issue that may cause the distal tip to detach from the delivery system during procedures.

The agency’s classification

FDA (Devices): Class I

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA has classified this as a Class I recall. Class I is defined in the severity rubric as meeting Severe criteria (score 4). Although no reported illnesses or injuries are mentioned in the source text, the agency's own classification dictates the severity level.

Plain-English summary

Medtronic Heart Valves Division is recalling the Harmony Delivery Catheter System in specific manufacturing lots worldwide. Devices in these lots contain inner shaft assemblies with a manufacturing issue that may increase the potential for the distal tip to detach from the delivery system under certain procedural or anatomical conditions.

The affected units were distributed worldwide, including throughout the United States and internationally to Argentina, Australia, Austria, Canada, Chile, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Mexico, Netherlands, Northern Ireland, Norway, Oman, Poland, Portugal, Puerto Rico, Qatar, Romania, Saudi Arabia, Spain, Sweden, Switzerland, Thailand, and the United Kingdom. A total of 1881 units are involved in this recall.

Healthcare providers and patients who have received or are scheduled to receive this device should contact Medtronic for information about the affected lot numbers and appropriate next steps. Patients with questions about their specific device should consult their healthcare provider.

The recalled product

Product: Medtronic Harmony Delivery Catheter System
Manufacturer: Medtronic Heart Valves Division
Category: Medical Device — Cardiac / Delivery System
Hazard: device-detachment
procedural-risk
Affected units: 1,881

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

GTIN 00763000341367
Lot Numbers: 0012508285
0012517045
0012526102
0012526103
0012614786
0012614787
0012623740
0012623741
0012642959
0012659419
0012663878
0012663879
0012690218
0012699635
0012702022
0012710787
0012728367
0012728369
0012777713

Distribution

Distributed nationwide across the United States.

Same manufacturer · Medtronic Heart Valves Division

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Same hazard · device detachment