Medtronic recalls Percepta CRT-P MRI SureScan devices with specific serial numbers due to a potential reset risk from timing interactions between the EffectivCRT Diagnostic and Ventricular Safety Pacing feature. Affected units include those with serial numbers listed in the recall notice.
Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT Diagnostic and the Ventricular Safety Pacing feature (VSP).
Medtronic is recalling certain Percepta CRT-P MRI SureScan devices that may reset due to a timing interaction between the EffectivCRT Diagnostic and Ventricular Safety Pacing feature. This could affect heart failure patients using these devices, though the risk is not immediately life-threatening.
The device may reset due to a timing interaction between the EffectivCRT Diagnostic and Ventricular Safety Pacing feature. This could cause the device to malfunction, but the risk is not immediately life-threatening.
Heart failure patients with implanted Percepta CRT-P MRI SureScan devices using the specific serial numbers listed in the recall notice. Patients with these devices are most at risk.
Check if your Percepta CRT-P MRI SureScan device has a serial number listed in the provided recall notice. The affected units have specific serial numbers starting with RNO (e.g., RNO201997H) or RNO600230S.
Look for the serial number on your device, which starts with RNO (e.g., RNO201997H) or RNO600230S.
If your device is listed in the recall, contact Medtronic for further instructions.
The Percepta CRT-P MRI SureScan is an implantable pulse generator for cardiac resynchronization therapy (CRT-P) used in heart failure patients.
Medtronic does not require replacement; they provide instructions for checking if your device is affected and contacting them for further steps.
The risk is low; the device may reset due to a timing interaction but is not immediately life-threatening.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2412-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2412-2018 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.
