Medtronic recalls Percepta Quad CRT-P MRI SureScan devices with specific serial numbers due to potential device reset from timing interactions between diagnostic features and safety pacing. Affected units may require medical evaluation.
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 Quad CRT-P MRI SureScan devices that may reset due to a timing interaction between the EffectivCRT Diagnostic and Ventricular Safety Pacing features. This could affect heart failure patients with implanted devices. If you have the recalled model, contact Medtronic for guidance.
The device may reset due to a timing interaction between the EffectivCRT Diagnostic feature and the Ventricular Safety Pacing (VSP) function. This could cause unintended device behavior but does not typically cause injury in normal use.
Heart failure patients with implanted Percepta Quad CRT-P MRI SureScan devices. Most at risk are those with specific serial numbers listed in the recall.
Check if your device has serial numbers starting with RNV60 followed by 5 digits (e.g., RNV601570S). The recall includes specific serial numbers listed in the official notice.
Look for the serial number on your device, which starts with RNV60 followed by 5 digits (e.g., RNV601570S).
If your device is listed in the recall, contact Medtronic directly for further instructions.
The recall does not require replacement; affected users should contact Medtronic for guidance.
The device is safe for normal use but may reset due to the timing interaction. Medical evaluation is recommended if you have the recalled model.
Check if your device has a serial number starting with RNV60 followed by 5 digits (e.g., RNV601570S) as listed in the official recall notice.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2415-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2415-2018 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.
