MEDICAL DEVICE RECALLCRITICAL

Medtronic Harmony Delivery Catheter System

Medtronic is recalling the Harmony Delivery Catheter System due to a manufacturing defect that may cause the distal tip to detach during use.

What to do

Healthcare providers should immediately stop using the affected delivery catheter systems and return them to Medtronic. Contact your Medtronic representative for instructions on returning the devices.

Recalled

2026-05-22

Listed

2026-07-02

Updated

2026-07-03

Recall No.

Z-2624-2026

Agency

FDA

Firm

Medtronic Heart Valves Division

Recall ID

99031

Status

ONGOING

Recall at a glance

Quantity recalled: 1881 units

Why it was recalled

Medtronic is recalling the Harmony Delivery Catheter System due to a manufacturing issue that may cause the distal tip to detach from the delivery system during use. This detachment can occur under certain procedural or anatomical conditions due to a defect in the inner shaft assemblies.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Medtronic Harmony Delivery Catheter System

Lot code: 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 (+31 more, see the official notice)
UDI-DI: 00763000341367, 0012508285, 0012517045, 0012526102, 0012526103, 0012614786, 0012614787, 0012623740, 0012623741, 0012642959, 0012659419, 0012663878, 0012663879, 0012690218, 0012699635, 0012702022, 0012710787, 0012728367, 0012728369, 0012777713

Where it was sold

Distributed nationwide.

Timeline

2026-05-22Firm initiated recall
2026-07-02Publicly announced
2026-07-03Listed on Recall Canary
2026-07-03Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-07-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification