{"url_path":"/fda/device/recalls/Z-2624-2026","section_key":"summary","section_title":"DEVICE Recall: Medtronic Heart Valves Division — Medtronic Harmony Delivery Catheter System","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-22","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2624-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Medtronic Heart Valves Division"},"word_count":239,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2624-2026\n\n**Recalling firm:** Medtronic Heart Valves Division\n**Classification:** Class I\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-22\n**Report date:** 2026-07-08\n\n## Product\nMedtronic Harmony Delivery Catheter System\n\n## Reason\nDevices 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.\n\n## Affected lots\nGTIN 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.\n\n## Distribution\nWorldwide 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."}