Medtronic recalls certain Sprint Quattro Lead Medical Device Identification Cards that incorrectly state patients have complete MR conditional systems. This could lead to unsafe MRI scans if the patient is mistakenly told they are MR safe.
The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted."
Medtronic is recalling specific Medical Device Identification Cards for Sprint Quattro Lead devices. These cards mistakenly state that patients have a complete MR conditional system, which could cause unsafe MRI scans if the patient is told they are MR safe.
The cards incorrectly state that patients have a complete MR conditional system. This could lead to unsafe MRI scans if the patient is told they are MR safe when they are not actually MR conditional.
Patients with Sprint Quattro Lead devices who received the recalled Medical Device Identification Cards. Those who have the specific serial numbers listed in the recall are most at risk.
Check for Medical Device Identification Cards with the Sprint Quattro Lead product (CFN 6935M72). Look for the specific serial numbers listed in the recall, such as TDL440798V or TDL098796V.
Review the card for the specific serial numbers listed in the recall to determine if it is affected.
The card incorrectly states that patients have a complete MR conditional system, which could lead to unsafe MRI scans if the patient is told they are MR safe.
Check for the specific serial numbers listed in the recall, such as TDL440798V or TDL098796V, on the Medical Device Identification Card.
Review the card for the specific serial numbers listed in the recall to determine if it is affected. If it is affected, contact Medtronic for further instructions.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0390-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0390-2022 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.
