microTargeting" Drive System, Product Number MT-DS
Reported: July 11, 2018 Initiated: May 10, 2018 #Z-2345-2018
Product Description
microTargeting" Drive System, Product Number MT-DS
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.
Details
- Recalling Firm
- FHC, Inc.
- Units Affected
- 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 Britain, Italy, Japan, Norway, Romania, South Africa, Switzerland, Saudi Arabia, Taiwan.
- Location
- Bowdoin, ME
Frequently Asked Questions
What product was recalled? ▼
microTargeting" Drive System, Product Number MT-DS. Recalled by FHC, Inc.. Units affected: 2952 total.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 11, 2018. Severity: Moderate. Recall number: Z-2345-2018.
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