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.
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.
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
- UPC
- 00763000341367, 0012508285, 0012517045, 0012526102, 0012526103, 0012614786, 0012614787, 0012623740, 0012623741, 0012642959, 0012659419, 0012663878, 0012663879, 0012690218, 0012699635, 0012702022, 0012710787, 0012728367, 0012728369, 0012777713
- Recall #
- Z-2624-2026
Where it was sold
Distributed nationwide.
Official source
Editorial summary by Recall Canary · last updated 2026-07-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification