Medical Device Identification Cards associated with recall
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
Why was Medical Device Identification Cards associated with 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."
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Quantity
- 187 Medical Device Cards
- Distribution
- US, Canada, Northern Mariana Islands
- Recall date
- December 22, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)