Use caution Medical device recall · FDA · Published May 22, 2026

Medtronic Harmony Catheter System Recall: Risk of Tip Detachment During Procedures

Medtronic recalls Harmony Delivery Catheter Systems with specific lot numbers due to potential distal tip detachment during procedures. Affected units may require replacement to prevent complications.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2624-2026Medical device Medtronic ›

Use caution until it’s fixed

Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.

Take action

Contact the company

Recalling firmMedtronic Heart Valves Division1851 E Deere Ave · Santa Ana, CA 92705-5720

✎ GovInfoNow plain-language explainer

Medtronic is recalling certain Harmony Delivery Catheter Systems that could detach at the tip during medical procedures. This risk might cause complications if the catheter becomes dislodged during use. Read more at govinfonow.com/recall/49078-medtronic-harmony-catheter-system-recall-risk-of-tip-detachment-during.

Source Summary by GovInfoNow · govinfonow.com/recall/49078-medtronic-harmony-catheter-system-recall-risk-of-tip-detachment-during · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2624-2026

Cite this page

“Medtronic Harmony Catheter System Recall: Risk of Tip Detachment During Procedures.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49078-medtronic-harmony-catheter-system-recall-risk-of-tip-detachment-during. Based on FDA recall #Z-2624-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2624-2026%22&limit=1).

The FDA announced on May 22, 2026, that Medtronic Heart Valves Division is recalling the Medtronic Harmony Delivery Catheter System due to a manufacturing issue that may cause the distal tip to detach. The agency classified this as a Class I recall affecting 1,881 units distributed worldwide.

How to tell if you have it

Medtronic Harmony Delivery Catheter System
UPC 00763000341367
UPC 00763000520151
UPC 00763000544027
UPC 00763000582951
UPC 00763000918712

The hazard

Context

GovInfoNow's records show Medtronic Heart Valves Division has two other recalls on record since October 23, 2020. On June 11, 2021, the division recalled the Medtronic CoreValve Evolut R Delivery Catheter due to actuator separation risk. On October 23, 2020, the division recalled the Medtronic Evolut R System for potential TAV leaflet damage during balloon dilatation. Other recent recalls of similar products include Medline Medical Procedure Kits Recall: Catheter Issues May Cause Detachment (May 4, 2026) and Medline Medical Procedure Kits: Catheter Issues May Cause Premature Detachment (May 4, 2026).

How to tell if you have this one

Check for the GTIN numbers 00763000341367, 00763000544027, 00763000520151, or 00763000582951 on the product packaging. Also look for the listed lot numbers in the recall notice.

Brand
Medtronic
Product
Medtronic Harmony Delivery Catheter System
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the GTIN and lot numbers on your catheter system to determine if it is affected by this recall.
Contact Medtronic
Reach out to Medtronic Heart Valves Division for guidance on next steps if your device is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Canada, Chile, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Mexico, Netherlands, Northern Ireland,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 47 days after the firm started it.

May 22, 2026Firm started the recall
Jul 2, 2026FDA classified it Class I
Jul 8, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More Medtronic recalls

Link to this recall

<a href="https://govinfonow.com/recall/49078-medtronic-harmony-catheter-system-recall-risk-of-tip-detachment-during">Medtronic Harmony Catheter System Recall: Risk of Tip Detachment During Procedures (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2624-2026 (May 22, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2624-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.