Medtronic Harmony Delivery Catheter System Recall: Capsule Bond Break Risk
Medtronic recalls Harmony Delivery Catheter System (HARMONY-DCS) due to potential capsule bond breaking during TPV valve replacement procedures. Affected lots listed in the recall notice.
Use caution until it’s fixed
There is potential for the capsule bond to break during the procedure.
Contact the company
What happened, in plain English
Medtronic is recalling its Harmony Delivery Catheter System used in pulmonary valve replacements because the capsule bond might break during the procedure. This could lead to complications for patients undergoing the surgery. Read more at govinfonow.com/recall/61009-medtronic-harmony-delivery-catheter-system-recall-capsule-bond-break-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/61009-medtronic-harmony-delivery-catheter-system-recall-capsule-bond-break-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0927-2022
Cite this page
“Medtronic Harmony Delivery Catheter System Recall: Capsule Bond Break Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61009-medtronic-harmony-delivery-catheter-system-recall-capsule-bond-break-risk. Based on FDA recall #Z-0927-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0927-2022%22&limit=1).
Why it’s dangerous
The capsule bond in the catheter system could break during the procedure, potentially causing complications such as bleeding or other issues for patients receiving the valve replacement. This risk occurs during the surgical implantation process.
Who’s affected
Patients undergoing pulmonary valve replacement surgery using the recalled Harmony Delivery Catheter System are most at risk. Healthcare providers using the system for implantation procedures may also be affected.
How to tell if you have this one
Check for the HARMONY-DCS (GTIN: 00763000341367) label on the catheter system. Affected lots include specific numbers listed in the recall notice, such as 0010519040 through 0010826593.
- Brand
Medtronic- Product
Medtronic Inc recalls Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation- Category
Medical device
What to do — step by step
Check Product Lot Number
Look for the lot numbers listed in the recall notice (0010519040 through 0010826593) on the Harmony Delivery Catheter System.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “US Nationwide and the countries of Canada.” 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 56 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-0927-2022 (March 2, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0927-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.