FDAFDA · Food and drugs·Recall number Z-0615-2024
Medtronic SynchroMed II, Model 8637-40, Programmable pump
Published January 3, 2024 · Recall initiated: November 13, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Neuromodulation
- Distributor
- Worldwide
- Lot
- GTIN 00613994483195, Serial Numbers: NGV502657H, NGV508302H, NGV612281H, NGV612282H, NGV717221H, NGV723564H, NGV727392H, NGV727397H, NGV727400H, NGV727906H, NGV730310H, NGV741180H; GTIN 00643169100824, Serial Numbers: NGV503518H, NGV503522H, NGV504577H, NGV504580H, NGV504581H, NGV507269H, NGV507271H, NGV507272H, NGV507273H, NGV507431H, NGV507433H, NGV507434H, NGV507436H, NGV508247H, NGV508248H, NGV508257H, NGV509489H, NGV509490H, NGV510082H, NGV512179H, NGV512180H, NGV502833H, NGV503294H, NGV502489H, NGV511809H, NGV510811H, NGV507369H, NGV511074H, NGV512393H, NGV502490H, NGV509057H, NGV506230H, NGV503295H, NGV507614H, NGV509098H, NGV509769H, NGV503297H, NGV502903H, NGV504121H, NGV511164H, NGV512019H, NGV502487H, NGV504523H, NGV503292H, NGV511885H, NGV511163H, NGV509373H, NGV502488H, NGV506232H, NGV510872H, NGV509770H, NGV510474H, NGV512471H, NGV508053H, NGV504241H, NGV507628H, NGV507635H, NGV503352H, NGV512033H, NGV512037H, NGV507723H, NGV508260H, NGV509172H, NGV509477H, NGV503596H, NGV504429H, NGV502450H, NGV507824H, NGV510692H, NGV505405H, NGV506725H, NGV511877H, NGV512666H, NGV505006H, NGV509513H, NGV500356H, NGV501018H, NGV503021H, NGV503099H, NGV503186H, NGV503187H, NGV503487H, NGV504710H, NGV504901H, NGV505165H, NGV508052H, NGV509450H, NGV509762H, NGV512254H, NGV513130H, NGV505328H, NGV506132H, NGV508199H, NGV504567H, NGV512052H, NGV501951H, NGV502809H, NGV502344H, NGV506202H, NGV505245H, NGV505772H, NGV508420H, NGV510444H, NGV510215H, NGV502774H, NGV504027H, NGV509803H, NGV511504H, NGV504240H, NGV504389H, NGV511052H, NGV504392H, NGV507692H, NGV509561H, NGV511591H, NGV500401H, NGV503155H, NGV503634H, NGV504300H, NGV504477H, NGV504499H, NGV504503H, NGV504866H, NGV505396H, NGV505728H, NGV506421H, NGV506888H, NGV507130H, NGV507553H, NGV510135H, NGV510995H, NGV511124H, NGV512684H, NGV501082H, NGV507786H, NGV500391H, NGV500398H, NGV507732H, NGV504276H, NGV500358H, NGV502146H, NGV510357H, NGV502422H, NGV502423H, NGV506876H, NGV509283H, NGV512496H, NGV513129H, NGV505345H, NGV509783H, NGV511611H, NGV511903H, NGV503233H, NGV502982H, NGV503659H, NGV505207H, NGV507109H, NGV511643H, NGV511698H, NGV511741H, NGV506755H, NGV502367H, NGV504370H, NGV504375H, NGV510066H, NGV505958H, NGV501978H, NGV502023H, NGV503397H, NGV503043H, NGV506006H, NGV508280H, NGV511149H, NGV511064H, NGV508139H, NGV504019H, NGV502608H, NGV505225H, NGV511757H, NGV506199H, NGV501014H, NGV501896H, NGV511111H, NGV511731H, NGV502132H, NGV506176H, NGV506204H, NGV506529H, NGV506554H, NGV507088H, NGV507165H, NGV507678H, NGV508306H, NGV510328H, NGV502994H, NGV505401H, NGV506284H, NGV507615H, NGV502156H, NGV505314H, NGV501090H, NGV505329H, NGV505457H, NGV505500H, NGV505648H, NGV509119H, NGV510330H, NGV511806H, NGV504679H, NGV507077H, NGV508938H, NGV513135H, NGV512645H, NGV504876H, NGV505939H, NGV507572H, NGV503898H, NGV512833H, NGV506826H, NGV508758H, NGV512338H, NGV502787H, NGV504247H, NGV507146H, NGV507573H, NGV510448H, NGV511060H, NGV511063H, NGV512164H, NGV505128H, NGV511725H, NGV501823H, NGV504275H, NGV504495H, NGV509382H, NGV511752H, NGV506188H, NGV509553H, NGV500349H, NGV509097H, NGV512565H, NGV507524H, NGV513125H, NGV510408H, NGV501983H, NGV505806H, NGV500384H, NGV501010H, NGV501011H, NGV507538H, NGV510807H, NGV501844H, NGV502044H, NGV502420H, NGV503287H, NGV503382H, NGV505310H, NGV505381H, NGV509055H, NGV502466H, NGV502738H, NGV502739H, NGV508421H, NGV508274H, NGV510338H, NGV507613H, NGV510040H, NGV510179H, NGV503750H, NGV511478H, NGV503534H, NGV505211H, NGV503488H, NGV512107H, NGV505139H, NGV506404H, NGV504012H, NGV504586H, NGV505301H, NGV505605H, NGV506027H, NGV506783H, NGV508317H, NGV508862H, NGV510792H, NGV510838H, NGV511535H, NGV512425H, NGV503938H, NGV504808H, NGV507173H, NGV508258H, NGV510565H, NGV504060H, NGV508220H, NGV510758H, NGV506221H, NGV509318H, NGV504017H, NGV504018H, NGV504955H, NGV507463H, NGV507647H, NGV507867H, NGV508956H, NGV510383H, NGV510386H, NGV512251H, NGV503114H, NGV505218H, NGV508259H, NGV510310H, NGV502571H, NGV512820H, NGV512838H,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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