Medtronic is recalling specific Micra pacemaker models (MC1VR01) for updated instructions on removing the tether during implant. This recall affects certain serial numbers sold only in the U.S. and requires updated instructions for safe implant procedures.
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 specific Micra pacemaker models (MC1VR01) that were sold only in the U.S. to update instructions for removing the tether during implant. This update ensures safe procedures for the pacemaker's release from the delivery system.
The recall updates instructions for removing the tether during implant to ensure the pacemaker can be safely released from the delivery system. This update addresses a procedural detail that was previously not clearly documented in the device's instructions.
Current owners of the specific Micra pacemaker models (MC1VR01) with serial numbers listed in the recall are affected. Patients with these devices are most at risk if they do not follow the updated instructions.
Check your Micra pacemaker's serial number against the list of affected numbers provided in the recall (e.g., MCR606940S, MCR606945S, etc.). The devices were sold only in the U.S. and are part of the Micra MC1VR01 model.
Compare your Micra pacemaker's serial number with the list of affected numbers provided in the recall (e.g., MCR606940S, MCR606945S, etc.).
Medtronic has updated the Micra Instructions for Use and the Micra Implant Procedure Tip Card to include specific information on tether removal during implant.
The Micra MC1VR01 model with specific serial numbers listed in the recall (e.g., MCR606940S, MCR606945S, etc.) is affected.
Medtronic is updating the Micra Instructions for Use and the Micra Implant Procedure Tip Card to include specific information on removing the tether during implant.
No action is needed if your Micra pacemaker's serial number is not listed in the recall.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2493-2019 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2493-2019 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.
