Z-2624-2026Class I

Medtronic Harmony Delivery Catheter System

Name: Z-2624-2026 Medtronic Harmony Delivery Catheter System
Creator: Medtronic Heart Valves Division
Published: 2026-05-22
License: https://open.fda.gov/license/

Medtronic Heart Valves Division / initiated 2026-05-22 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Heart Valves Division began a recall of Medtronic Harmony Delivery Catheter System on 2026-05-22. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2624-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-05-22
Posted: 2026-07-02
Recalling firm: Medtronic Heart Valves Division
Product: Medtronic Harmony Delivery Catheter System
Product code: NPV Pulmonary Valve Prosthesis Percutaneously Delivered
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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."
Quantity in commerce: 1881 units
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 codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2624-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2624-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02

Product code NPV

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)