Data Foundry

Medical device recalls 2026

Medtronic Harmony Delivery Catheter System — Class I medical device recall Z-2624-2026

Ongoing recall by Medtronic Heart Valves Division, reported 2026-07-08, distributed nationwide. Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for

Recall numberZ-2624-2026
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMedtronic Heart Valves Division, Santa Ana, CA, United States
Recall initiated2026-05-22
Classified2026-07-02
Reported by FDA2026-07-08
DistributedNationwide (US)
Countries outside the USAR, AT, AU, CA, CH, CL, DE, DK, ES, FI, FR, GB, HK, IE, IL, IN, IT, JO, JP, MX, NL, NO, OM, PL, PT, QA, RO, SA, SE, TH
Quantity1,881 units
Reason classesdevice malfunction
UPC / GTIN / UDI-DI00763000341367, 00763000520151, 00763000544027, 00763000582951, 00763000918712
Lot numbers0012508285, 0012517045, 0012526102, 0012526103, 0012575897, 0012590535, 0012606411, 0012606413, 0012614786, 0012614787, 0012623740, 0012623741, 0012635392, 0012642959, 0012642964, 0012642965, 0012659418, 0012659419, 0012663878, 0012663879, 0012676200, 0012678282, 0012690207, 0012690218, 0012690219, 0012699635, 0012699637, 0012702022, 0012710787, 0012728367, 0012728368, 0012728369, 0012777713, 0012804151, 0012804152, 0012804579, 0012804580, 0012824770, 0012824771, 0012874526 and 31 more

Product

Medtronic Harmony Delivery Catheter System

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2624-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.