FDA Device recall Z-0615-2024

Medtronic SynchroMed II, Model 8637-40, Programmable pump

FDA Device
Class II
ongoing
Published 2024-01-03

On 2024-01-03 the FDA classified a Class II recall of Medtronic SynchroMed II, Model 8637-40, Programmable pump by Medtronic Neuromodulation, citing 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….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0615-2024
Classification	Class II
Status	ongoing
Initiated	2023-11-13
Published	2024-01-03
Last updated	2026-09-13 11:56 UTC
Company	Medtronic Neuromodulation
Distribution	n/a

Product

Medtronic SynchroMed II, Model 8637-40, Programmable pump

Reason

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.

Identifiers

code_info	GTIN 00613994483195, Serial Numbers: NGV502657H, NGV508302H, NGV612281H, NGV612282H, NGV717221H, NGV723564H, NGV727392… 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,

code_info

GTIN 00613994483195, Serial Numbers: NGV502657H, NGV508302H, NGV612281H, NGV612282H, NGV717221H, NGV723564H, NGV727392…

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,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0615-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.