NIM Vital recallZ-1223-2022 · Medtronic Xomed, Inc. · initiated May 3, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Xomed, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Software anomaly was identified.
FDA root cause category: Software Design Change
What the company is doing
The firm issued a recall notification to consignees on 05/03/2022 via mail. The letter instructs the consignee to follow the IFU regarding the setup and "Lead Off Detected" error message, forward the notification to those who need to be aware within the organization and to any location which the devices have been distributed, and to complete the response form. An additional correction notification was sent on about 09/13/2023 to notify consignees of the update availability (NIM Vital" SW version v1.4.3) to fix this issue.
Recall details
- Recall number
- Z-1223-2022
- Status
- Open, Classified
- Initiated by the company
- May 3, 2022
- Posted by the FDA
- Jun 2, 2022
- Recalling firm
- Medtronic Xomed, Inc.
- Quantity
- 18 units
- Product code
- GWF
- FDA submissions
- K200759
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France.
Product description
NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
Code information (models, lots, serial numbers)
Model Number: NIM4CM01; UDI/DI: 00763000395896, lot numbers: C2026207, C2026233, C2026320, C2026335, C2026354, C2026376, C2110046, C2110089, C2110131, C2110196, C2110198, C2110208, C2110217, C2110223 and 00763000002978, lot numbers: C1915048, C1915078, C1915099, C1915188, C2026207, C2026233, C2026320, C2026335, C2026354, C2026376, C2110046, C2110089, C2110131, C2110196, C2110198, C2110208, C2110217, C2110223.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- NIM Vital™ NIM4CM01Medtronic Xomed, Inc. · STIMULATOR, ELECTRICAL, EVOKED RESPONSE3 recalls795 reports
- NIM Vital™ NIM4CM01Medtronic Xomed, Inc. · STIMULATOR, ELECTRICAL, EVOKED RESPONSE3 recalls47 reports
Product lines
Other devices under the same FDA submission
7 devices cleared under K200759 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- NIM Vital™ NIM4CPB1Medtronic Xomed, Inc. · STIMULATOR, ELECTRICAL, EVOKED RESPONSE3 recalls331 reports
- NIM Vital NIM4CM01Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls260 reports
- NIM Vital NIM4CPB1Medtronic Xomed, Inc. · Stimulator, electrical, evoked response2 recalls208 reports
- NIM Vital™ NIM4CPB1Medtronic Xomed, Inc. · STIMULATOR, NERVE3 recalls45 reports
- NIM Vital NIM4CM01RFMedtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls8 reports
- NIM Vital NIM4CPB1RFMedtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls1 report
- NIM Vital™ NIM4CPB2Medtronic Xomed, Inc. · STIMULATOR, NERVE1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 90163).
- Z-1224-2022 · Open, ClassifiedNIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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