FHC Recalls
17 recalls on record · July 11, 2018 to November 20, 2024 · Medical Devices
Recalls by year
18
20
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 20, 2024Medical DevicesFDA
FHC, Inc. recalls microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode o
Hazard: A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too long relative to the size of other components was included in the build order for Lot 244517 of P/N 66-IT-06P. Use of the product with a spacer tube which is too long could result in intercranial hemorrhaging and brain damage.
July 15, 2020Medical DevicesFDA
FHC, Inc. recalls FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological
Hazard: An electrical sub-circuit was not properly connected. Its purpose is to eliminate the possibility of interference with proper performance of the Guideline 5 Main Processing Unit, if an ESD event (greater than 6kV) were to occur.
July 11, 2018Medical DevicesFDA
FHC, Inc. recalls microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),
Hazard: 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.
July 11, 2018Medical DevicesFDA
FHC, Inc. recalls microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002
Hazard: 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.
July 11, 2018Medical DevicesFDA
FHC, Inc. recalls microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001
Hazard: 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.
July 11, 2018Medical DevicesFDA
FHC, Inc. recalls microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601
Hazard: 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.
July 11, 2018Medical DevicesFDA
FHC, Inc. recalls microTargeting" Drive System Distributed by Medtronic, Product Number FC1006
Hazard: 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.
July 11, 2018Medical DevicesFDA
FHC, Inc. recalls microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB
Hazard: 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.
July 11, 2018Medical DevicesFDA
FHC, Inc. recalls microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB
Hazard: 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.
July 11, 2018Medical DevicesFDA
FHC, Inc. recalls microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME
Hazard: 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.
July 11, 2018Medical DevicesFDA
FHC, Inc. recalls microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
Hazard: 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.
July 11, 2018Medical DevicesFDA
FHC, Inc. recalls microTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME
Hazard: 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.
July 11, 2018Medical DevicesFDA
FHC, Inc. recalls microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA
Hazard: 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.
July 11, 2018Medical DevicesFDA
FHC, Inc. recalls microTargeting" Drive System, Product Number 66-ZD-MD-01
Hazard: 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.
July 11, 2018Medical DevicesFDA
FHC, Inc. recalls microTargeting" Drive System, Product Number 66-ZD-MD
Hazard: 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.
July 11, 2018Medical DevicesFDA
FHC, Inc. recalls microTargeting" Drive System, Product Number MT-DS-01
Hazard: 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.
July 11, 2018Medical DevicesFDA
FHC, Inc. recalls microTargeting" Drive System, Product Number MT-DS
Hazard: 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.