Reported Apr 26, 2023 · Ongoing
Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling…
Medtronic Neuromodulation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568
Is this the product you have?
- 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
- Lot codes and dates
- UDI/DI00763000426361
- Serial Numbers
73 of 73 codes
HG56BR6HG56C4RHG56CJAH01HG56CLEHG586N7HG586UMHG58704HG58VM0HG58VQHHG58VQHH01HG58VY5HG58W7HHG58WWCHG58WYBHG58WYBH01HG58X0EHG597BHHG597DHHG597M8HG59ABHHG59AFCHG59AV6HG59RY0HG5A9GTHG5A9VYHG5A9VZHG5AQH0HG5AQQEHG5BQ5YHG5BQLRHG5BQPJHG5BTW7HG5BTZXHG5BU5WHG5BU77HG5EPSBHG5EQ0CHG5EQ2AHG5EQ69HG5F31NHG5F338HG5F3AZHG5F3EHHG5F3G6HG5F3K5HG5F3NFHG5FP0YHG5FP3BHG5FP70HG5FP70H01HG5FPBEHG5HQBMHG5HQF8HG5LJTLHG5LJZQHG5LK2JHG5LK4HHG5LK5YHG5LK7CHG5LK8P
- Serial Numbers
HG59ABHHG59RY0HG59SJ4HG59SNCHG5A9H3HG5A9NBHG5A9VYHG5BQ5YHG5BQAWHG5BQLR
- Amount recalled
- 1414 units
Where it was sold
- Nationwide
Why it was recalled
Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been machined on only one side. As a result, the dual carrier cannot be used to pass two extensions simultaneously.
This product could cause temporary or reversible health problems — stop using it.
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