Vanta INS Neurostimulator May Fail to Communicate with Programmer Systems
Medtronic has recalled certain Vanta INS Implantable Neurostimulator devices that may fail to communicate with clinical or patient programmer systems, preventing proper monitoring and therapy adjustments.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II device recall involving a malfunction that prevents essential communication between an implanted neurostimulator and its programmer systems. While no illnesses or injuries have been reported, the failure to communicate poses a risk of harm by preventing patients from receiving proper monitoring and therapy adjustments.
Plain-English summary
Medtronic Neuromodulation has recalled approximately 1,021 Vanta INS Implantable Neurostimulator devices (Model 977006) used for pain management therapy. The devices are part of a neurostimulation system designed to work with clinical and patient programmer systems for monitoring and managing therapy.
The devices may be susceptible to communication failures between the implanted neurostimulator and the programmer systems. When this malfunction occurs, clinicians and patients may be unable to check device status, adjust therapy settings, or access other essential functions required for proper patient care.
The affected devices were distributed worldwide, including throughout the United States and in multiple European countries. Patients with affected devices should contact their healthcare provider or Medtronic to determine if their device serial number is included in this recall.
Patients should not stop pain therapy without consulting their physician. Healthcare providers should work with Medtronic to arrange any necessary device evaluation or replacement.
The recalled product
- Product
- Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy.
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 1,021
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model 977006 1) GTIN/UPN: 00763000518615: Expiration Date: 03/14/2023
- Serial Numbers: NMS500202H
- NMS500236H
- NMS500243H
- NMS500248H
- NMS500253H
- NMS500261H
- NMS500262H
- NMS500265H
- NMS500266H
- NMS500267H
- NMS500269H
- NMS500270H
- NMS500271H
- NMS500272H
- NMS500273H
- NMS500274H
- NMS500275H
- NMS500276H
- NMS500277H
Distribution
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