Medtronic recalls ID cards for Astra XT DR implantable pulse generators that incorrectly state patients have complete MR conditional systems. This may cause unnecessary MRI risks. Check your card's serial numbers for affected units.
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 ID cards for some Astra XT DR implantable pulse generators because they incorrectly state patients have complete MRI-safe systems. This could lead to unsafe MRI procedures if patients are mistakenly told they can undergo MRI scans without precautions.
The ID cards mistakenly list patients as having complete MRI-safe systems. This could cause patients to be incorrectly told they can safely undergo MRI scans without proper safety checks, potentially leading to injury from MRI procedures.
Patients with Astra XT DR implantable pulse generators who received the recalled ID cards. Those at most risk are individuals who might undergo MRI scans without proper safety checks due to the incorrect statement.
Check your Astra XT DR implantable pulse generator's ID card for serial numbers: RNH655287S, RNH648107S, RNH645452S, RNH634608S, RNH642593S, RNH638740S, RNH635040S, RNH636809S, RNH633755S, or RNH612514S.
Look for the serial numbers listed on the ID card to confirm if it's affected.
The ID card incorrectly states patients have complete MRI-safe systems, which could lead to unsafe MRI procedures if patients are not properly checked.
Check the serial numbers on your ID card: RNH655287S, RNH648107S, RNH645452S, RNH634608S, RNH642593S, RNH638740S, RNH635040S, RNH636809S, RNH633755S, or RNH612514S.
The recall does not require action beyond checking if your ID card has the listed serial numbers.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0391-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0391-2022 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.
