Recall Z-2624-2026
Medtronic Heart Valves Division · initiated May 22, 2026
Class I – dangerous or defective products that could cause serious health problems or death
Product
Medtronic Harmony Delivery Catheter System
Codes / 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…
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.
FDA-determined cause: Process control
Action taken
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 RS.CFQFCA@medtronic.com. 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."
Details
- Recall number
- Z-2624-2026
- Initiated
- May 22, 2026
- Posted by FDA
- July 2, 2026
- Product code
- NPV – Pulmonary Valve Prosthesis Percutaneously Delivered
- Quantity
- 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.
- Recalling firm
- Medtronic Heart Valves Division, Santa Ana, CA