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microTargeting™ Insertion Tube 66-IT-IT2P-00769

by Fhc, Inc. GUDID

Listed FDA GUDID listing, no authorization on record Open recall

Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00873263007693 UDI-DIDate8 May 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

8 recalls · 1 ongoing · FDA

    • Ongoing Z-0312-2025 FDA Class I initiated 4 Oct 2024

    A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too long relative to the size of other components was included in the build order for Lot 244517 of P/N 66-IT-06P. Use of the product with a spacer tube which is too long could result in intercranial hemorrhaging and brain damage.

  • 6 recalls, same reason

    • Terminated Z-2346-2018 FDA Class II initiated 10 May 2018
    • Terminated Z-2355-2018 FDA Class II initiated 10 May 2018
    • Terminated Z-2348-2018 FDA Class II initiated 10 May 2018
    • Terminated Z-2356-2018 FDA Class II initiated 10 May 2018
    • Terminated Z-2347-2018 FDA Class II initiated 10 May 2018
    • Terminated Z-2345-2018 FDA Class II initiated 10 May 2018

    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.

    • Terminated Z-0895-05 FDA Unclassified (pre-2012) initiated 14 Mar 2005

    Potential for non-sterile pin to contaminate sterile field

Specification

GUDID

Trade Name
microTargeting™ Insertion Tube
Generic Name
Intracerebral cannula, nonimplantable, single-use
Model / Ref / Catalog
66-IT-IT2P-00769, 66-IT-IT2P
Primary DI / UDI-DI
00873263007693
510(k) Number
FDA Product Code
HAW
GMDN Term
Intracerebral cannula, nonimplantable, single-use
Device Class
Class II
Regulation Number
882.4560
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Related devices

Cleared under the same submission (K011775)

Show all (12)

Other devices from Fhc, Inc.

See all devices from Fhc, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No