FDAFDA · Food and drugs·Recall number Z-2493-2019
Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.
Published September 18, 2019 · Recall initiated: August 6, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during implant.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Distributor
- Worldwide
- Lot
- GTIN 00643169529731, Serial Numbers: MCR606940S MCR606945S MCR606947S MCR606948S MCR606949S MCR606951S MCR606953S MCR606955S MCR606956S MCR606958S MCR606962S MCR606963S MCR606964S MCR606966S MCR606967S MCR606969S MCR606970S MCR606971S MCR606972S MCR606973S MCR606974S MCR606975S MCR606977S MCR606981S MCR606982S MCR606983S MCR606985S MCR606987S MCR606988S MCR606989S MCR606990S MCR606991S MCR606992S MCR606993S MCR606994S MCR606995S MCR606996S MCR606997S MCR606998S MCR606999S MCR607000S MCR607001S MCR607002S MCR607003S MCR607005S MCR607006S MCR607009S MCR607010S MCR607011S MCR607012S MCR607013S MCR607014S MCR607015S MCR607017S MCR607018S MCR607019S MCR607020S MCR607021S MCR607022S MCR607023S MCR607026S MCR607027S MCR607028S MCR607029S MCR607030S MCR607031S MCR607032S MCR607033S MCR607035S MCR607040S MCR607041S MCR607042S MCR607043S MCR607044S MCR607045S MCR607046S MCR607047S MCR607048S MCR607049S MCR607050S MCR607051S MCR607052S MCR607053S MCR607056S MCR607058S MCR607060S MCR607061S MCR607062S MCR607063S MCR607064S MCR607065S MCR607066S MCR607068S MCR607070S MCR607071S MCR607074S MCR607075S MCR607077S MCR607079S MCR607080S MCR607081S MCR607082S MCR607083S MCR607084S MCR607087S MCR607089S MCR607091S MCR607092S MCR607093S MCR607094S MCR607095S MCR607097S MCR607098S MCR607099S MCR607101S MCR607102S MCR607103S MCR607104S MCR607105S MCR607106S MCR607108S MCR607109S MCR607110S MCR607111S MCR607112S MCR607114S MCR607115S MCR607116S MCR607117S MCR607119S MCR607120S MCR607121S MCR607122S MCR607123S MCR607124S MCR607125S MCR607126S MCR607128S MCR607129S MCR607130S MCR607132S MCR607133S MCR607136S MCR607137S MCR607138S MCR607140S MCR607141S MCR607142S MCR607143S MCR607144S MCR607146S MCR607147S MCR607148S MCR607149S MCR607175S MCR607176S MCR607177S MCR607178S MCR607179S MCR607180S MCR607181S MCR607182S MCR607183S MCR607185S MCR607186S MCR607187S MCR607188S MCR607190S MCR607192S MCR607193S MCR607194S MCR607196S MCR607197S MCR607199S MCR607200S MCR607202S MCR607203S MCR607204S MCR607205S MCR607206S MCR607209S MCR607210S MCR607212S MCR607213S MCR607214S MCR607216S MCR607217S MCR607218S MCR607221S MCR607222S MCR607223S MCR607227S MCR607229S MCR607230S MCR607231S MCR607234S MCR607235S MCR607236S MCR607238S MCR607239S MCR607242S MCR607243S MCR607244S MCR607245S MCR607246S MCR607249S MCR607250S MCR607251S MCR607252S MCR607253S MCR607254S MCR607255S MCR607256S MCR607257S MCR607258S MCR607259S MCR607260S MCR607262S MCR607263S MCR607264S MCR607265S MCR607266S MCR607267S MCR607269S MCR607270S MCR607272S MCR607274S MCR607276S MCR607278S MCR607282S MCR607283S MCR607284S MCR607285S MCR607286S MCR607289S MCR607291S MCR607292S MCR607297S MCR607298S MCR607302S MCR607304S MCR607305S MCR607306S MCR607307S MCR607308S MCR607310S MCR607311S MCR607312S MCR607313S MCR607314S MCR607315S MCR607316S MCR607317S MCR607318S MCR607319S MCR607320S MCR607321S MCR607322S MCR607323S MCR607324S MCR607325S MCR607326S MCR607327S MCR607328S MCR607329S MCR607330S MCR607331S MCR607332S MCR607333S MCR607334S MCR607337S MCR607338S MCR607339S MCR607340S MCR607342S MCR607343S MCR607344S MCR607346S MCR607347S MCR607348S MCR607349S MCR607350S MCR607351S MCR607352S MCR607356S MCR607357S MCR607360S MCR607361S MCR607364S MCR607365S MCR607366S MCR607367S MCR607368S MCR607371S MCR607372S MCR607373S MCR607375S MCR607376S MCR607377S MCR607379S MCR607380S MCR607381S MCR607382S MCR607383S MCR607384S MCR607385S MCR607386S MCR607387S MCR607388S MCR607391S MCR607393S MCR607394S MCR607395S MCR607396S MCR607397S MCR607398S MCR607399S MCR607403S MCR607404S MCR607405S MCR607406S MCR607407S MCR607408S MCR607410S MCR607411S MCR607412S MCR607413S MCR607414S MCR607415S MCR607416S MC
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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