Harmony recallZ-2624-2026 · Medtronic Heart Valves Division · initiated May 22, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Heart Valves Division or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
Medtronic issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 5/28/2026 via mail or email. The notice explained the issue, potential risk, and requested the following: " - Review your inventory for affected lot numbers listed. - If unused inventory from the listed lot numbers is located, immediately quarantine and return the affected units to Medtronic by contacting Customer Service at 1-800-854-3570, Option 1 then Option 4, and referencing this communication to initiate return and exchange or credit of the affected units. Your Medtronic sales representative can assist in the return of the affected units as necessary. - Please share this notification with implanters and teams within your organization. If product listed above has been forwarded from your facility to another facility, please notify the other facility of this Medtronic Urgent Medical Device Recall. - Complete the enclosed Customer Confirmation Form and email to [email protected]. This form must be returned even if you do not have the affected units in your possession. - Please maintain a copy of this communication in your records."
Recall details
- Recall number
- Z-2624-2026
- Status
- Open, Classified
- Initiated by the company
- May 22, 2026
- Posted by the FDA
- Jul 2, 2026
- Recalling firm
- Medtronic Heart Valves Division
- Quantity
- 1881 units
- Product code
- NPV
- FDA submissions
- P200046
- 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, Norway, Oman, Poland, Portugal, Puerto Rico, Qatar, Romania, Saudi Arabia, Spain, Sweden, Switzerland, Thailand, United Kingdom.
Product description
Medtronic Harmony Delivery Catheter System
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
GTIN 00763000341367, Lot Numbers: 0012508285, 0012517045, 0012526102, 0012526103, 0012614786, 0012614787, 0012623740, 0012623741, 0012642959, 0012659419, 0012663878, 0012663879, 0012690218, 0012699635, 0012702022, 0012710787, 0012728367, 0012728369, 0012777713, 0012804152, 0012804579, 0012824770, 0012824771, 0012874526, 0012896853, 0012896884, 0012910323, 0012965210, 0012965211, 0012976400, 0012986693, 0013063766, 0013063767, 0013105039, 0013105040, 0013133457, 0013181623, 0013181624, 0013236643, 0013272796, 0013272798. GTIN 00763000544027, Lot Numbers: 0012508285, 0012526103, 0012614786, 0012614787, 0012623740, 0012623741, 0012642959, 0012659419, 0012663879, 0012702022, 0012710787, 0012728367, 0012728369, 0012777713, 0012804152, 0012804579, 0012824771, 0012874526, 0012896853, 0012896884, 0012910323, 0012965211, 0012976400, 0012986693, 0013063767, 0013105039, 0013105040, 0013133457, 0013181623, 0013181624. GTIN 00763000520151, Lot Numbers: 0012575897, 0012642965, 0012728368, 0013272799. GTIN 00763000582951, Lot Numbers: 0012590535, 0012606411, 0012606413, 0012642964, 0012659418, 0012678282, 0012690219, 0012699637, 0012804151, 0012804580, 0012874527, 0012888682, 0012896885, 0012965221, 0012986699, 0013063764, 0013063765, 0013105037, 0013227504. GTIN 00763000918712, Lot Numbers: 0012635392, 0012676200, 0012690207, 0012874528, 0012874529, 0013015539, 0013105038.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Harmony™ HARMONY-DCSMedtronic, Inc. · Pulmonary valve prosthesis percutaneously delivered2 recalls35 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under P200046 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Harmony™ HARMONY-25Medtronic, Inc. · Pulmonary valve prosthesis percutaneously delivered3 deaths151 reports
- Harmony™ HARMONY-22Medtronic, Inc. · Pulmonary valve prosthesis percutaneously delivered8 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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