Medtronic is recalling specific Micra MC1VR01 single-chamber pacemakers (US only) to update instructions for safe removal of the tether during implant procedures. Affected units have serial numbers listed in the recall notice.
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.
Medtronic is recalling certain single-chamber Micra pacemakers (model MC1VR01) for US customers to update instructions on safely removing the tether during implant procedures. This update ensures proper removal of the pacemaker from the delivery system without risk.
The recall updates the instructions for removing the tether to safely release the pacemaker from the delivery system during implant procedures. This update addresses a potential risk of improper removal that could affect device function.
US customers with the specific Micra MC1VR01 single-chamber pacemakers listed in the recall notice. Patients with these devices are most at risk.
Check your device's serial number against the list of affected units provided in the recall notice. The affected units are single-chamber Micra pacemakers with model MC1VR01 and serial numbers starting with MCR610462S through MCR619799S.
Verify your Micra pacemaker's serial number against the list of affected units provided in the recall notice.
Medtronic will provide updated instructions for safely removing the tether during implant procedures.
Medtronic is recalling specific Micra MC1VR01 single-chamber pacemakers (US only) to update instructions for safely removing the tether during implant procedures.
Check your device's serial number against the list of affected units starting with MCR610462S through MCR619799S provided in the recall notice.
Medtronic will provide updated instructions for safely removing the tether during implant procedures. No action is required for the device itself.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2492-2019 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2492-2019 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
