Medtronic SenSight Extension Tunneler Kit: manufacturing defect prevents dual-extension passage
Medtronic recalled approximately 1414 SenSight Extension Tunneler Kits due to a manufacturing defect where dual carriers were machined on only one side, preventing use for passing two extensions simultaneously.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II classification with no reported injuries, illnesses, or adverse events. The defect prevents intended dual-extension functionality but does not create an inherent safety hazard.
Plain-English summary
The Medtronic SenSight Extension Tunneler Kit (REF B31030) is a surgical instrument designed to assist in tunneling and passage of extensions for deep brain stimulation procedures. Medtronic recalled approximately 1414 units after receiving reports of a manufacturing defect in which dual carriers were machined on only one side, preventing them from passing two extensions simultaneously as intended.
The affected devices were distributed worldwide, including throughout the United States and to facilities in Austria, Belgium, France, Germany, Italy, Japan, Netherlands, Spain, Switzerland, and the United Kingdom, among other countries. Affected units are identified by specific serial numbers and UDI/DI codes that have been provided to healthcare providers.
The recalled product
- Product
- Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and passage of extensions for deep brain stimulation
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 1,414
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)
- UDI/DI00763000426361
- Serial Numbers: HG56BR6
- HG56C4R
- HG56CJAH01
- HG56CLE
- HG586N7
- HG586UM
- HG58704
- HG58VM0
- HG58VQH
- HG58VQHH01
- HG58VY5
- HG58W7H
- HG58WWC
- HG58WYB
- HG58WYBH01
- HG58X0E
- HG597BH
- HG597DH
- HG597M8
Distribution
Distributed nationwide across the United States.
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