FDAMay 10, 2018device
microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
fhc
UPCs
00873263002162
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAmicroTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.2024-10-04
- FDAFHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments. Catalogue Number: C0215 UDI: 008732630067402020-06-17
- FDAmicroTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME2018-05-10
- FDAmicroTargeting" Drive System, Product Number 66-ZD-MD-012018-05-10
- FDAmicroTargeting" STar" Drive System (Manual), Product Number ST-DS-MA2018-05-10
- FDAmicroTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME2018-05-10
- FDAmicroTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB2018-05-10
- FDAmicroTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB2018-05-10
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