Medtronic StimLoc Burr Hole Cover Recalled for Excess Nylon Flash on Clip
Medtronic is recalling StimLoc Burr Hole Cover neurosurgical devices and related components due to excess nylon flash on the clip. The defect could affect device function during implantation or use.
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: FDA Class II recall for a manufacturing defect affecting a high-risk neurosurgical implant device without reported injuries or illnesses. Excess nylon flash on a DBS device component represents potential mechanical risk, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Neuromodulation is recalling specific lots of the StimLoc Burr Hole Cover and related Deep Brain Stimulation (DBS) leads and components. The recall is due to excess nylon flash on the clip—excess plastic material that can result from the manufacturing process.
The StimLoc Burr Hole Cover is a neurosurgical implant device used in deep brain stimulation procedures. The excess nylon flash could potentially interfere with proper device function or cause mechanical issues during implantation or use.
Approximately 15,192 units have been distributed across all 50 states, the District of Columbia, and Hawaii. Multiple product lines and part numbers are affected by this recall.
Healthcare facilities and physicians should immediately cease use of affected lots and consult Medtronic's instructions for guidance on device replacement or corrective actions. Patients who have received these implants should contact their healthcare provider for further guidance.
The recalled product
- Product
- Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 15,192
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)
- a) PART NUMBER: 3387S-40 - DBS Lead with StimLoc LOTS # : VA21YUS
- VA24RVV
- VA25SDK
- VA26Q2S
- VA27X8H
- VA2980G
- VA29Z9A
- VA2DA2Z
- VA21ZJU
- VA24S65
- VA25WK1
- VA26XP2
- VA27ZRF
- VA29814
- VA2A5MJ
- VA2DA5Y
- VA21ZYP
- VA24S66
- VA2613V
- VA26ZFU
Distribution
Related recalls
Same manufacturer · Medtronic Neuromodulation
See all →- ModerateMedtronic 2x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
- ModerateMedtronic 1x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
- HighMedtronic SynchroMed Flex Infusion Programmer Software Application
FDA (Devices) · 2026-05-20
- ModerateNeurostimulator clinician programmer app recalled over faults during device use
FDA (Devices) · 2026-01-21
- HighFemoral nails, 360 mm left trochanteric, recalled over undersized shaft diameter
FDA (Devices) · 2025-12-31
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighMedtronic Recalls Deep Brain Stimulation Lead Kits Due to Depth Stop Defect
FDA (Devices) · 2017-08-30
- HighMedtronic Recalls Deep Brain Stimulation Extension Kits Due to Impedance Reports
FDA (Devices) · 2015-05-27
- HighMedtronic Recalls DBS Lead Kits Due to Potential Insulation Damage
FDA (Devices) · 2016-08-31
- ModerateDBS Lead Device Recall: Use By Date Label Discrepancy
FDA (Devices) · 2023-11-08
- SevereMedtronic Recalls Deep Brain Stimulation Lead Kits Due to Damage Risk
FDA (Devices) · 2013-05-08
- HighDeep brain stimulation burr hole kits recalled over retaining clip closing resistance
FDA (Devices) · 2025-08-27