Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0390-2022

November 08, 2021

Class II

Product summary

Firm
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Event
Event 89054
Status
Terminated
Classification
Class II
Quantity
187 Medical Device Cards
Official record key
device-enforcement:Z-0390-2022

Official wording

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."

Code information: 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

Distribution pattern: US, Canada, Northern Mariana Islands

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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."