FDA recall, , High risk
Medtronic Harmony Delivery Catheter System
The Medtronic Harmony Delivery Catheter System may have an increased potential for distal tip detachment under certain conditions.
Summary by Recall Canary from the FDA notice
What happened
Medtronic Heart Valves Division, located in Santa Ana, California, recalled the Medtronic Harmony Delivery Catheter System because 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. The company began the recall on May 22, 2026, and the FDA added it to the Enforcement Report on July 2, 2026.
The recall affects 1881 units distributed worldwide, including the US Nationwide and countries such as 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, and the United Kingdom.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI and lot code are listed under that product.
Incomplete list: 40 of 71 lot codes shown.
A UDI-DI is the device identifier printed with the barcode on the device label.
Medtronic Harmony Delivery Catheter System
- UDI-DI
- 00763000341367
- 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
- 00763000544027
- 00763000520151
- 0012575897
- 0012642965
- 0012728368
- 0013272799
- 00763000582951
- 0012590535
- 0012606411
- 0012606413
- 0012642964
- 0012659418
- 0012678282
- 0012690219
- 0012699637
- 0012804151
- 0012804580
- 0012874527
- 0012888682
- 0012896885
- 0012965221
- 0012986699
- 0013063764
- 0013063765
- 0013105037
- 0013227504
- 00763000918712
- 0012635392
- 0012676200
- 0012690207
- 0012874528
- 0012874529
- 0013015539
- 0013105038
- 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
Recall details
- Company began the recall
- Sold in
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.
- Company
- Medtronic Heart Valves DivisionSanta Ana, California
- Hazard
- Manufacturing problem
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 99031
- Recall number
- Z-2624-2026
- Quantity recalled
- 1881 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
