Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72

Recall number

Z-0390-2022

Recalling firm

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Product

Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72

Status

Terminated

Initiated

2021-11-08

Posted

not on file

Terminated

2026-05-04

Reason

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."

Root cause

Error in labeling

Action

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.

Quantity

187 Medical Device Cards

Distribution

US, Canada, Northern Mariana Islands

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

["P920015"]

Product code

NVY

Firm FEI

2182208

Firm city

Mounds View

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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