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Z-2624-2026Class I

Medtronic Heart Valves Division

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Medtronic Heart Valves Division
Product type
Device
Status
Ongoing
Report date
2026-07-08
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.
Firm state
CA
Product quantity
1881 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
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.

Product description

Medtronic Harmony Delivery Catheter System

Code / lot info

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.

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Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →