FDA (Devices) recall action 80148
The FDA (Devices) publishes a recall like this one as 15 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 15 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
FHC, Inc. is recalling the microTargeting STar Drive System (Manual) because the Depth Stop Adapter may damage the lead and stylet if the screw is over-tightened.
FHC, Inc. is recalling the microTargeting Drive System Depth Stop Adapter because over-tightening the screw can damage implanted leads, requiring replacement.
FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage implanted leads, requiring surgical replacement.
FHC, Inc. is recalling Depth Stop Adapters because over-tightening the screw can damage implanted leads, requiring removal and replacement.
FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage the implanted lead, requiring removal and replacement.
FHC, Inc. is recalling the microTargeting Drive System Depth Stop Adapter because over-tightening the screw can damage implanted leads, requiring replacement.
FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage implanted leads and stylets, requiring replacement.
FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage implanted leads, causing short circuits and requiring replacement.
FHC, Inc. is recalling microTargeting Lead Adapters because over-tightening the depth stop screw can damage the lead and stylet, potentially requiring surgical replacement.
FHC, Inc. is recalling the microTargeting STar Drive System (Manual) because the Depth Stop Adapter can damage implanted leads if over-tightened, requiring replacement.
FHC, Inc. is recalling 2,952 microTargeting Drive Systems because over-tightening the depth stop screw can damage implanted leads, requiring replacement.
FHC, Inc. is recalling the microTargeting Drive System because the Depth Stop Adapter may damage implanted leads if over-tightened, potentially requiring replacement.
FHC, Inc. is recalling the microTargeting Drive System because the Depth Stop Adapter can damage implanted leads and stylets when over-tightened, requiring device replacement.
FHC, Inc. is recalling microTargeting Lead Adapters because over-tightening the depth stop screw can damage implanted leads, requiring replacement.
FHC, Inc. is recalling the microTargeting Drive System because the Depth Stop Adapter can damage leads and stylets, potentially causing short circuits.