Device recall: microTargeting" Drive System, Product Number MT-DS
Class II FDA enforcement event 80148. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
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
FHC, Inc. started this device recall on 10 May 2018. The firm address in the FDA record is in Bowdoin, ME. FDA put the recall in Class II. FDA event 80148 has 15 product records. The first FDA enforcement report date is 11 Jul 2018. The record gives the status Terminated, with the termination date 30 Apr 2019.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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,…
Recalling firm
FHC, Inc., Bowdoin, ME.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
15 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2345-2018 | microTargeting" Drive System, Product Number MT-DS | 2952 total | Class II | Terminated | 11 Jul 2018 |
| Z-2346-2018 | microTargeting" Drive System, Product Number MT-DS-01 | 2952 total | Class II | Terminated | 11 Jul 2018 |
| Z-2347-2018 | microTargeting" Drive System, Product Number 66-ZD-MD | 2952 total | Class II | Terminated | 11 Jul 2018 |
| Z-2348-2018 | microTargeting" Drive System, Product Number 66-ZD-MD-01 | 2952 total | Class II | Terminated | 11 Jul 2018 |
| Z-2349-2018 | microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA | 2952 total | Class II | Terminated | 11 Jul 2018 |
| Z-2350-2018 | microTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME | 2952 total | Class II | Terminated | 11 Jul 2018 |
| Z-2351-2018 | microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA | 2952 total | Class II | Terminated | 11 Jul 2018 |
| Z-2352-2018 | microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME | 2952 total | Class II | Terminated | 11 Jul 2018 |
| Z-2353-2018 | microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB | 2952 total | Class II | Terminated | 11 Jul 2018 |
| Z-2354-2018 | microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB | 2952 total | Class II | Terminated | 11 Jul 2018 |
| Z-2355-2018 | microTargeting" Drive System Distributed by Medtronic, Product Number FC1006 | 2952 total | Class II | Terminated | 11 Jul 2018 |
| Z-2356-2018 | microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601 | 2952 total | Class II | Terminated | 11 Jul 2018 |
| Z-2357-2018 | microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001 | 2952 total | Class II | Terminated | 11 Jul 2018 |
| Z-2358-2018 | microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002 | 2952 total | Class II | Terminated | 11 Jul 2018 |
| Z-2359-2018 | microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8), | 2952 total | Class II | Terminated | 11 Jul 2018 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2018
- 1,074
- Share of these events in Class II
- 92%
- Product records in this event
- 15Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 4 Oct 2024 | microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode o | Device | Class I | 1 |
| 17 Jun 2020 | FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological a | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-2345-2018The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 80148. https://recallregister.com/fda/ii/80148/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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,…
- What quantity of product is in FDA event 80148?
- The event has 15 product records. The first record gives this quantity:
2952 total
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2018 have the same class?
- 92% of the 1,074 device events that started in 2018 are in Class II.