Medtronic recalls Vanta with AdaptiveStim Implantable Neurostimulator Model 977006 due to potential spinal chord stimulation causing device failure. Two patients reported explant procedures after the issue occurred.
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.
Medtronic is recalling Vanta with AdaptiveStim Implantable Neurostimulator Model 977006 devices because a cardioversion procedure may damage the electronics, making the device unresponsive. This has led to two explant procedures in patients.
A cardioversion procedure (a type of electrical shock treatment) can damage the electronics in the Vanta device, causing it to become unresponsive and non-functional. This has resulted in two patients needing explant procedures (removal of the device) as of April 19, 2023.
Patients with the recalled Vanta with AdaptiveStim Implantable Neurostimulator Model 977006 devices are most at risk. The issue affects those who have undergone spinal cord stimulation procedures.
Check your device for the model number 977006. The serial numbers listed in the recall include many NMS50xxxxH codes. The GTIN is 00763000411923.
Look for the model number 977006 on your Vanta with AdaptiveStim Implantable Neurostimulator device.
If you have the recalled device, contact Medtronic directly for further instructions.
The recalled model is 977006 for the Vanta with AdaptiveStim Implantable Neurostimulator.
As of April 19, 2023, Medtronic has received two complaints from patients with the recalled device that resulted in explant procedures.
The recall requires you to check if your device is affected and contact Medtronic for instructions. The device may need to be removed if it has been damaged by a cardioversion procedure.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2036-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2036-2023 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
