Reported Aug 30, 2017 · Terminated
DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and…
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 · Minneapolis, MN · 55421-1241
Is this the product you have?
- DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to multiple accessories used in DBS lead implant procedures. Among these accessories is the DBS lead holder, also referred to as the lead depth stop. The lead holder affixes to the DBS lead during the lead implant procedure, marking the distance to the lead tip and providing control of DBS lead depth during implant by interfacing with the stereotactic system
- Lot codes and dates
2,716 of 2,716 codes
Model 3387Lot Serial #: 02068802940206882647020688277902068827800206882781020688278202068827830206886184020688632302068863280206886330020688633102068863320206886333020688660302068878130206890443020689044402069034880206903489020690679202069067930206907159020691639102069163920206916393020691639402069163950206916396020691639702069163980206916399020691679702069171200206917121020691712202069171230206917124020691712502069171260206917127020691712802069171290206917130020691713102069171320206917302020691730302069173040206917306020691730702069173080206917310020691731202069175600206917561020691756302069175640206917565
- Amount recalled
- 86,024
Where it was sold
Why it was recalled
Medtronic received reports that the DBS depth stop did not adequately secure to the lead, which can result in DBS lead placement beyond the intended target.
This product could cause temporary or reversible health problems — stop using it.
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