Recall Z-2346-2018— FHC, Inc.

Name: FDA recall Z-2346-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-10

Class II · Terminated

Class II FDA medical device recall by FHC, Inc., initiated 2018-05-10, terminated 2019-04-30. It names one FDA 510(k) clearance: K011775. Product: microTargeting" Drive System, Product Number MT-DS-01. Reason: 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..

Recalling firm: FHC, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-05-10
Terminated: 2019-04-30
Firm location: Bowdoin, ME, United States

510(k) clearances named in this recall

1 on FDA's record

K011775 — MICRO TARGETING DRIVE SYSTEMFHC, Inc.·cleared 2001-08-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

microTargeting" Drive System, Product Number MT-DS-01

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.