Medical Device Identification Cards associated with Sprint… recallZ-0390-2022 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · initiated Nov 8, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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."
FDA root cause category: Error in labeling
What the company is doing
On 09-Nov-2021, Medtronic initiated mailing the patient letter, including a corrected Medical Device Identification Card, to impacted patients. In addition, on 08-Nov-2021, physicians following impacted patients were sent a physician letter explaining the correction.
Recall details
- Recall number
- Z-0390-2022
- Status
- Terminated
- Initiated by the company
- Nov 8, 2021
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Quantity
- 187 Medical Device Cards
- Product code
- NVY
- FDA submissions
- P920015
- Distribution
- US, Canada, Northern Mariana Islands
Product description
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
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, TDL187462V
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- Sprint Quattro Secure S® 6935M72Medtronic, Inc. · Permanent defibrillator electrodes1 recall1 death120 reports
- Sprint Quattro Secure S® 6935M72Medtronic, Inc. · Permanent defibrillator electrodes1 recall13 reports
- Sprint Quattro Secure S® 6935M72Medtronic, Inc. · permanent pacemaker Electrode1 recall11 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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