Medtronic Neuromodulation: Medtronic SynchroMed II, Model 8637-40, Programmable pump

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide Quantity: 78532 units Lot/code info: 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

UPC codes

00613994483195, 00643169100824, 00643169345218, 00643169345225

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.