Recall Z-3069-2017— Medtronic Neuromodulation
Class II · Terminated
Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2017-03-17, terminated 2021-04-22. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: 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..
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-03-17
- Terminated
- 2021-04-22
- Firm location
- Minneapolis, MN, United States
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.