Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 6, 2014
Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic Nexframe Stereotactic System for the precise positioning of microelectrodes and implantable leads. A stereotactic guidance system used in conjunction with Medtronic StealthStation Navigation Systems-image-guided surgery (IGS) systems-for Deep Brain Stimulation (DBS) procedures.
Potential for misalignment of the Z-stage scale. Using one of these devices for a procedure could result in the microelectrode being inserted to an incorrect target depth.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Neuromodulation recalled Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in co… - a moderate-severity action.
Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in co… was recalled by Medtronic Neuromodulation in August 6, 2014. Reason: Potential for misalignment of the Z-stage scale. Using one of these devices for a procedure could result in t…. Check the official notice for the remedy. Verify recall #Z-2118-2014 with the FDA Devices before acting.
The recall
Medtronic Neuromodulation issued this moderate-severity FDA Devices recall-Potential for misalignment of the Z-stage scale. Using one of these devices for a procedure could result in t….
- Moderate
- severity level
- Class II
- classification
- August 6, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2118-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2118-2014) was formally reported on August 6, 2014, with the manufacturer initiating the action on June 11, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Neuromodulation is listed as the recalling firm, operating out of Minneapolis, MN. Federal records list the affected scope as 300 EXPANDED 10/02/2014 130 devices.
The documented reason for this recall is: Potential for misalignment of the Z-stage scale. Using one of these devices for a procedure could result in the microelectrode being inserted to an incorrect target depth. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA including CA, CO, FL, IL, KS, KY, LA, MN, MT, NC, NE, OR, TX, VA, and UT, and Internationally to Canada, Spain, and United Kingdom.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
300 EXPANDED 10/02/2014 130 devices
Related Recalls
6
3 from same agency
Product description
Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic Nexframe Stereotactic System for the precise positioning of microelectrodes and implantable leads. A stereotactic guidance system used in conjunction with Medtronic StealthStation Navigation Systems-image-guided surgery (IGS) systems-for Deep Brain Stimulation (DBS) procedures.
Reason for recall
Potential for misalignment of the Z-stage scale. Using one of these devices for a procedure could result in the microelectrode being inserted to an incorrect target depth.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2118-2014 |
| Date reported | August 6, 2014 |
| Date initiated | June 11, 2014 |
| Recalling firm | Medtronic Neuromodulation |
| Firm location | Minneapolis, MN |
| Affected scope | 300 EXPANDED 10/02/2014 130 devices |
| Distribution | Worldwide Distribution - USA including CA, CO, FL, IL, KS, KY, LA, MN, MT, NC, NE, OR, TX, VA, and UT, and Internationally to Canada, Spain, and United Kingdom. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2118-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic Nexframe Stereotactic System for the precise positioning of microelectrodes and implantable leads. A stereotactic guidance system used in conjunction with Medtronic StealthStation Navigation Systems-image-guided surgery (IGS) systems-for Deep Brain Stimulation (DBS) procedures.. Recalled by Medtronic Neuromodulation. Units affected: 300 EXPANDED 10/02/2014 130 devices.
Why was this product recalled? ▼
Potential for misalignment of the Z-stage scale. Using one of these devices for a procedure could result in the microelectrode being inserted to an incorrect target depth.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 6, 2014. Severity: Moderate. Recall number: Z-2118-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA including CA, CO, FL, IL, KS, KY, LA, MN, MT, NC, NE, OR, TX, VA, and UT, and Internationally to Canada, Spain, and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2118-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 6, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.