FDA Device recall Z-2036-2023

Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006

FDA Device
Class II
ongoing
Published 2023-07-05

On 2023-07-05 the FDA classified a Class II recall of Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006 by Medtronic Neuromodulation, citing A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic has received a total….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2036-2023
Classification	Class II
Status	ongoing
Initiated	2023-06-06
Published	2023-07-05
Last updated	2026-09-13 11:56 UTC
Company	Medtronic Neuromodulation
Distribution	n/a

Product

Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation

Reason

A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic has received a total of two complaints concerning this issue from patients implanted with a Vanta INS, both of which have resulted in explant procedures.

Identifiers

code_info	GTIN 00763000411923, Serial/Lot Numbers: NMS504094H, NMS504258H, NMS504861H, NMS503154H, NMS503612H, NMS503371H, NMS50… GTIN 00763000411923, Serial/Lot Numbers: NMS504094H, NMS504258H, NMS504861H, NMS503154H, NMS503612H, NMS503371H, NMS503748H, NMS504643H, NMS504701H, NMS504404H, NMS504802H, NMS504344H, NMS504771H, NMS504778H, NMS504650H, NMS501450H, NMS504544H, NMS501538H, NMS503203H, NMS503064H, NMS501373H, NMS503404H, NMS504791H, NMS504792H, NMS501978H, NMS502528H, NMS501313H, NMS501469H, NMS503521H, NMS502644H, NMS504254H, NMS502974H, NMS504955H, NMS503078H, NMS503079H, NMS504657H, NMS501285H, NMS501484H, NMS504381H, NMS501266H, NMS502517H, NMS502681H, NMS504772H, NMS501163H, NMS504243H, NMS502056H, NMS504636H, NMS505065H, NMS503237H, NMS501226H, NMS502346H, NMS502407H, NMS503392H, NMS503395H, NMS504259H, NMS504337H, NMS504402H, NMS504606H, NMS504610H, NMS505010H, NMS505012H, NMS505013H, NMS505014H, NMS505015H, NMS503450H, NMS504406H, NMS505034H, NMS504527H, NMS501897H, NMS504444H, NMS504523H, NMS504981H, NMS503627H, NMS502402H, NMS503862H, NMS501278H, NMS501953H, NMS502022H, NMS504561H, NMS504740H

code_info

GTIN 00763000411923, Serial/Lot Numbers: NMS504094H, NMS504258H, NMS504861H, NMS503154H, NMS503612H, NMS503371H, NMS50…

GTIN 00763000411923, Serial/Lot Numbers: NMS504094H, NMS504258H, NMS504861H, NMS503154H, NMS503612H, NMS503371H, NMS503748H, NMS504643H, NMS504701H, NMS504404H, NMS504802H, NMS504344H, NMS504771H, NMS504778H, NMS504650H, NMS501450H, NMS504544H, NMS501538H, NMS503203H, NMS503064H, NMS501373H, NMS503404H, NMS504791H, NMS504792H, NMS501978H, NMS502528H, NMS501313H, NMS501469H, NMS503521H, NMS502644H, NMS504254H, NMS502974H, NMS504955H, NMS503078H, NMS503079H, NMS504657H, NMS501285H, NMS501484H, NMS504381H, NMS501266H, NMS502517H, NMS502681H, NMS504772H, NMS501163H, NMS504243H, NMS502056H, NMS504636H, NMS505065H, NMS503237H, NMS501226H, NMS502346H, NMS502407H, NMS503392H, NMS503395H, NMS504259H, NMS504337H, NMS504402H, NMS504606H, NMS504610H, NMS505010H, NMS505012H, NMS505013H, NMS505014H, NMS505015H, NMS503450H, NMS504406H, NMS505034H, NMS504527H, NMS501897H, NMS504444H, NMS504523H, NMS504981H, NMS503627H, NMS502402H, NMS503862H, NMS501278H, NMS501953H, NMS502022H, NMS504561H, NMS504740H

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-2036-2023%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.