The Recall Desk
HighFDA (Devices)·Z-2228-2021·Announced 2021-08-18

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.

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: 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
Category
Medical Device — Neurosurgical Implant
Hazard
  • manufacturing-defect
  • mechanical-defect

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

Distributed in 46 states:

  • AL
  • AR
  • AZ
  • CA
  • CO
  • CT
  • DC
  • FL
  • GA
  • IA
  • ID
  • IL
  • IN
  • KS
  • KY
  • LA
  • MA
  • MD
  • ME
  • MI
  • MN
  • MO
  • MS
  • MT
  • NC
  • NE
  • NH
  • NJ
  • NM
  • NV
  • NY
  • OH
  • OK
  • OR
  • PA
  • RI
  • SC
  • SD
  • TN
  • TX
  • UT
  • VA
  • VT
  • WA
  • WI
  • WV

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