Recall Z-2354-2018
FHC, Inc. · initiated May 10, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB
Codes / lots: UDI: 00873263002643
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.
FDA-determined cause: Device Design
Action taken
Urgent Medical Device Recall notification letters were sent to customers on 5/10/18. The letters included the following instructions: FHC, Inc. Field Representatives will review your inventory and replace effected Depth Stop Adapters you have on hand with an improved design. In the interim, we advise that you do not over-tighten the Depth Stop Adapter screw. If low impedances or a short circuit is found, physicians should replace the lead prior to use and report the issue to FHC, Inc. or your local field rep.
Details
- Recall number
- Z-2354-2018
- Initiated
- May 10, 2018
- Terminated
- April 30, 2019
- Product code
- HAW – Neurological Stereotaxic Instrument
- Quantity
- 2952 total
- Distribution
- The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The devices were distributed to the following foreign countries: Argentina, Australia, Canada, Columbia, Denmark, Ecuador, France, Germany, Great…
- Recalling firm
- FHC, Inc., Bowdoin, ME
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2345-2018 Class II | microTargeting" Drive System, Product Number MT-DSThe FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-2346-2018 Class II | microTargeting" Drive System, Product Number MT-DS-01The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-2347-2018 Class II | microTargeting" Drive System, Product Number 66-ZD-MDThe FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-2348-2018 Class II | microTargeting" Drive System, Product Number 66-ZD-MD-01The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-2349-2018 Class II | microTargeting" STar" Drive System (Manual), Product Number ST-DS-MAThe FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-2350-2018 Class II | microTargeting" STar" Drive System (Motorized), Product Number ST-DS-METhe FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-2351-2018 Class II | microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MAThe FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-2352-2018 Class II | microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-METhe FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-2353-2018 Class II | microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DBThe FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-2355-2018 Class II | microTargeting" Drive System Distributed by Medtronic, Product Number FC1006The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-2356-2018 Class II | microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-2357-2018 Class II | microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number…The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-2358-2018 Class II | microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number…The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-2359-2018 Class II | microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |