Medtronic Harmony Delivery Catheter System

FDA device recall Z-2624-2026 · posted 2026-07-02 · Open, Classified

Recall details

Recalling firm

Medtronic Heart Valves Division

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.

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."

Root cause

Process control

Status

Open, Classified

Product code

NPV

Quantity affected

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, Me

Date initiated

2026-05-22

Date posted

2026-07-02

Location

Santa Ana, CA