microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001
Reported: July 11, 2018 Initiated: May 10, 2018 #Z-2357-2018
Product Description
microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001
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" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001. 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-2357-2018.
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