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Lower risk Medical device recall · FDA · Published November 8, 2021

Medtronic Sprint Quattro Lead Medical Device ID Cards Have Incorrect MRI Safety Statement

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0390-2022Medical deviceMedtronic ›
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Contact the company

Recalling firmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)8200 Coral Sea St Ne · Mounds View, MN 55112-4391
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/61561-medtronic-sprint-quattro-lead-medical-device-id-cards-have-incorrect.

Source Summary by GovInfoNow · govinfonow.com/recall/61561-medtronic-sprint-quattro-lead-medical-device-id-cards-have-incorrect · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0390-2022

Cite this page

“Medtronic Sprint Quattro Lead Medical Device ID Cards Have Incorrect MRI Safety Statement.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61561-medtronic-sprint-quattro-lead-medical-device-id-cards-have-incorrect. Based on FDA recall #Z-0390-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0390-2022%22&limit=1).

The FDA announced on 2021-11-08 that Medtronic Inc. is recalling Medical Device Identification Cards associated with Sprint Quattro Leads because some cards contain an erroneous statement claiming patients have a complete MR conditional system implanted. This recall affects 187 units distributed in the US, Canada, and Northern Mariana Islands.

How to tell if you have it

  • Brand: Medtronic
  • Product: Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
  • UDI: 00643169550919, Serial Numbers: TDL440798V through TDL199017V (full list provided in record)
  • UDI: 00613994718877, Serial Numbers: TDL098796V, TDL046363V, TDL016560V, TDL016558V, TDL016557V, TDL002704V, TDL010685V
  • UDI: 00643169309784, Serial Numbers: TDL192485V, TDL187462V

The hazard

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."

Context

GovInfoNow's records show Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 29 other recalls on record since 2017-12-19. Other recent recalls of similar products include Medtronic CRT-D DTBC2D1 Implantable Defibrillators (2023-05-10), Medtronic Cobalt CRT-D Defibrillators (2022-06-22), and Medtronic C304-HIS Device Recall (2022-04-20). Other recent recalls of similar products include Philips Brilliance CT 64 Medical Scanner Recall (2026-08-07), Philips Allura Cardio Vascular-Allura Centron X-Ray System Recall (2026-06-17), and Philips IntraSight Plus Software Error May Cause Wrong Patient Diagnosis (2026-08-06).

How to tell if you have this one

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.

  • Brand
    Medtronic
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    US, Canada, Northern Mariana Islands
Recall numberProduct, codes & lotsQuantity
Z-0390-2022Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72; Sprint Quattro Lead, Product/CFN 6935M72, UDI 00643169550919, Serial Numbers: TDL440798V, TDL475850V, TDL473645V, TDL386490V, TDL446689V, TDL458696V, TDL398634V, TDL440035V, TDL458694V, TDL397987V, TDL469404V, TDL469730V, TDL469411V, TDL473637V, TDL434492V, TDL433920V, TDL469403V, TDL397982V, TDL448256V, TDL398632V, TDL424268V, TDL448531V, TDL458699V, TDL460247V, TDL410929V, TDL405398V, TDL440809V, TDL448519V, TDL410295V, TDL410332V, TDL445702V, TDL368164V, TDL378146V, TDL446690V, TDL386481V, TDL458695V, TDL448518V, TDL448258V, TDL433896V, TDL446674V, TDL397974V, TDL386494V, TDL429017V, TDL397966V, TDL369718V, TDL424266V, TDL445620V, TDL445705V, TDL440984V, TDL440027V, TDL386489V, TDL403279V, TDL405769V, TDL434493V, TDL440803V, TDL445618V, TDL448527V, TDL433902V, TDL440971V, TDL440977V, TDL393417V, TDL433899V, TDL445712V, TDL403276V, TDL410915V, TDL433921V, TDL410334V, TDL414801V, TDL395189V, TDL429015V, TDL410291V, TDL410296V, TDL445703V, TDL368162V, TDL397975V, TDL393407V, TDL401828V, TDL423546V, TDL410331V, TDL431773V, TDL345939V, TDL350436V, TDL410916V, TDL368172V, TDL386480V, TDL440026V, TDL386477V, TDL410328V, TDL410301V, TDL410912V, TDL397992V, TDL344964V, TDL397985V, TDL431745V, TDL349616V, TDL405394V, TDL369722V, TDL433898V, TDL433909V, TDL424273V, TDL393401V, TDL423555V, TDL424267V, TDL397955V, TDL410905V, TDL349118V, TDL423556V, TDL350442V, TDL386479V, TDL368161V, TDL431777V, TDL431778V, TDL330398V, TDL381963V, TDL326160V, TDL345936V, TDL414787V, TDL386499V, TDL424269V, TDL386495V, TDL397967V, TDL405399V, TDL327272V, TDL405767V, TDL386493V, TDL315797V, TDL414793V, TDL386486V, TDL410341V, TDL386487V, TDL361821V, TDL386476V, TDL397983V, TDL312450V, TDL395193V, TDL378138V, TDL393408V, TDL337172V, TDL321443V, TDL395190V, TDL386496V, TDL397977V, TDL326159V, TDL369709V, TDL386497V, TDL369720V, TDL397958V, TDL298585V, TDL321456V, TDL386483V, TDL369713V, TDL397973V, TDL386498V, TDL386485V, TDL349115V, TDL336148V, TDL393409V, TDL344961V, TDL350065V, TDL337169V, TDL393405V, TDL349559V, TDL343795V, TDL393400V, TDL294118V, TDL393403V, TDL316186V, TDL368175V, TDL337170V, TDL326110V, TDL316181V, TDL323585V, TDL321171V, TDL315812V, TDL316169V, TDL276334V, TDL298584V, TDL199017V UDI 00613994718877, Serial Numbers: TDL098796V, TDL046363V, TDL016560V, TDL016558V, TDL016557V, TDL002704V, TDL010685V UDI 00643169309784, Serial Numbers: TDL192485V, TDL187462V187 Medical Device Cards
Z-0391-2022Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator; Astra XT DR implantable pulse generator, Product Number/CFN X2DR01, UDI 00763000108953, Serial Numbers: RNH655287S, RNH648107S, RNH645452S, RNH634608S, RNH642593S, RNH638740S, RNH635040S, RNH636809S, RNH633755S UDI 00643169634671, Serial Numbers: RNH612514S10 Medical Device Cards
Based on the official FDA remedy

What to do — step by step

  1. Check Card Details

    Review the card for the specific serial numbers listed in the recall to determine if it is affected.

How this recall unfolded

Recall timeline

FDA terminated this recall 4.5 years after the firm started it.

1. Firm started the recall: Nov 8, 202112. FDA classified it Class II: Dec 16, 202123. Published in FDA’s Enforcement Report: Dec 22, 202134. FDA terminated the recall: May 4, 2026420212026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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.

  • Official source: FDA Recall #Z-0390-2022 (November 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0390-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA