Medtronic Micra MC1VR01 — Class II medical device recall Z-2492-2019
Terminated recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), reported 2019-09-18. Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include
| Recall number | Z-2492-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN, United States |
| Recall initiated | 2019-08-06 |
| Classified | 2019-09-09 |
| Reported by FDA | 2019-09-18 |
| Terminated | 2023-06-26 |
| Quantity | 24,521 units |
| UPC / GTIN / UDI-DI | 00643169529748, 00643169711761 |
| Serial numbers | 43748S, 60740S, MCR6, MCR610462S, MCR610483S, MCR610486S, MCR610498S, MCR610503S, MCR610514S, MCR610516S, MCR610517S, MCR610523S, MCR610525S, MCR610526S, MCR610527S, MCR610529S, MCR610533S, MCR610537S, MCR610538S, MCR610542S, MCR610543S, MCR610546S, MCR610547S, MCR610551S, MCR610554S and 475 more |
| Model numbers | MC1VR01US |
Product
Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.
Reason for recall
Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during implant.
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-2492-2019. 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.