Recall Z-2357-2018— FHC, Inc.
Class II · Terminated
Class II FDA medical device recall by FHC, Inc., initiated 2018-05-10, terminated 2019-04-30. It names one FDA 510(k) clearance: K092562. Product: microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001. Reason: The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure..
- Recalling firm
- FHC, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-10
- Terminated
- 2019-04-30
- Firm location
- Bowdoin, ME, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001
Reason for recall
The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure.
Data sourced from openFDA. This site is unofficial and independent of the FDA.