FHC Depth Stop Adapter Recalled for Lead and Stylet Damage
FHC, Inc. is recalling the microTargeting Drive System because the Depth Stop Adapter can damage leads and stylets, potentially causing short circuits.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves significant injury reports, specifically the need to remove and replace implanted leads due to device damage.
Plain-English summary
FHC, Inc. is recalling the microTargeting Drive System, Product Number 66-ZD-MD-01, due to a defect in the FHC Depth Stop Adapter. The agency classifies this as a Class II recall.
The 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. The source text states that this issue has resulted in the need to remove and replace the implanted lead intraoperatively or in a follow-up procedure.
A total of 2,952 units were distributed to various US states and foreign countries. 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 also distributed to Argentina, Australia, Canada, Columbia, Denmark, Ecuador, France, Germany, Great Britain, Italy, Japan, Norway, Romania, South Africa, Switzerland, Saudi Arabia, and Taiwan.
The recalled product
- Product
- microTargeting" Drive System, Product Number 66-ZD-MD-01
- Manufacturer
- FHC, Inc.
- Affected units
- 2,952
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 00873263003565
Distribution
Part of a larger recall action
This product is one of 15 recalled by FHC, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 15 products in this recall →Related recalls
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