FDA Device recall Z-2493-2019
Medtronic Micra MC1VR01, REF MC1VR01 (OUS only)
- FDA Device
- Class II
- terminated
- Published 2019-09-18
On 2019-09-18 the FDA classified a Class II recall of Medtronic Micra MC1VR01, REF MC1VR01 (OUS only) by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing 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 Mic….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2493-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-06 |
| Published | 2019-09-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | n/a |
Product
Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.
Reason
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.
Identifiers
| code_info | GTIN 00643169529731, Serial Numbers: MCR606940S MCR606945S MCR606947S MCR606948S MCR606949S MCR606951S MCR606953…GTIN 00643169529731, Serial Numbers: MCR606940S MCR606945S MCR606947S MCR606948S MCR606949S MCR606951S MCR606953S MCR606955S MCR606956S MCR606958S MCR606962S MCR606963S MCR606964S MCR606966S MCR606967S MCR606969S MCR606970S MCR606971S MCR606972S MCR606973S MCR606974S MCR606975S MCR606977S MCR606981S MCR606982S MCR606983S MCR606985S MCR606987S MCR606988S MCR606989S MCR606990S MCR606991S MCR606992S MCR606993S MCR606994S MCR606995S MCR606996S MCR606997S MCR606998S MCR606999S MCR607000S MCR607001S MCR607002S MCR607003S MCR607005S MCR607006S MCR607009S MCR607010S MCR607011S MCR607012S MCR607013S MCR607014S MCR607015S MCR607017S MCR607018S MCR607019S MCR607020S MCR607021S MCR607022S MCR607023S MCR607026S MCR607027S MCR607028S MCR607029S MCR607030S MCR607031S MCR607032S MCR607033S MCR607035S MCR607040S MCR607041S MCR607042S MCR607043S MCR607044S MCR607045S MCR607046S MCR607047S MCR607048S MCR607049S MCR607050S MC |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2493-2019%22
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