Medtronic Heart Valves Division: Medtronic Harmony Delivery Catheter System

Recall number

Z-2624-2026

Recalling firm

Medtronic Heart Valves Division

Product

Medtronic Harmony Delivery Catheter System

Status

Open, Classified

Initiated

2026-05-22

Posted

2026-07-02

Terminated

not on file

Reason

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

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 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."

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.

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

["P200046"]

Product code

NPV

Firm FEI

2025587

Firm city

Santa Ana

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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