microTargeting" Drive System, Product Number MT-DS
FDA Recall Z-2345-2018 · Posted None
Recalling FirmFHC, Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2018-05-10
Date Terminated2019-04-30
Product Quantity2952 total
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.
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
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 Britain, Italy, Japan, Norway, Romania, South Africa, Switzerland, Saudi Arabia, Taiwan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.