Medtronic Nexdrive Micropositioning Drive Recalled for Potential Misalignment
Medtronic is recalling Nexdrive Micropositioning Drives because a scale misalignment could cause microelectrodes to be inserted at incorrect depths during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a high-risk medical device where a defect could lead to incorrect surgical depth, representing a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Medtronic Neuromodulation is recalling the Nexdrive Micropositioning Drive, models ML-1000 and ML-2000. These devices are used with the Medtronic Nexframe Stereotactic System to position microelectrodes and implantable leads during Deep Brain Stimulation (DBS) procedures.
The recall is due to a potential misalignment of the Z-stage scale. If a device with this defect is used, the microelectrode may be inserted to an incorrect target depth.
Approximately 300 units were distributed worldwide, including in the United States and internationally to Canada, Spain, and the United Kingdom. Healthcare facilities should stop using the affected devices and contact Medtronic for instructions on replacement or repair.
The recalled product
- Product
- 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…
- Manufacturer
- Medtronic Neuromodulation
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 (14)
- Lot numbers: 082605614
- 082601414
- 082602014
- 082634313
- 082630913
- 082629713
- 082629613
- 082626913
- 082623113
- 082621413
- and 082618213. EXPANDED 10/02/2014 Lot Numbers: 082616214
- 082616314
- 082618314
- and 082618414.
Distribution
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