FDA Medical Device Recalls (openFDA)
FHC, Inc.: FC400SP microTargeting StimPilot Single Procedure Kit Distributed by Medtronic Inc., Minneapolis, MN Ref: FHC4000SP Intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain.
- Recall number
- Z-0499-2009
- Recalling firm
- FHC, Inc.
- Product
- FC400SP microTargeting StimPilot Single Procedure Kit Distributed by Medtronic Inc., Minneapolis, MN Ref: FHC4000SP Intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain.
- Status
- Terminated
- Initiated
- 2008-10-20
- Posted
- 2008-12-18
- Terminated
- 2012-05-02
- Reason
- Mislabeled: May contain an electrode longer than labeled size
- Root cause
- Pending
- Action
- FHC notified customers via an Urgent: Medical Device Recall letter dated 10/20/08 advising users to remove the recalled electrodes from inventory and set the product aside for inspection by your FHC representative. Customers were asked to document their actions by completing the enclosed form and faxing it back to FHC at 207-666-8539.
- Quantity
- 23 kits (46 electrodes-2 electrodes/kit)
- Distribution
- Nationwide Distribution --- including states of CA, CO, FL, LA, NM, PA, TN, and PR.
- Lot, serial or model codes
- Serial numbers: 01689 through 01708 and 01756 through 01758.
- 510(k) numbers
- ["K991522"]
- PMA numbers
- not on file
- Product code
- GZL
- Firm FEI
- 3002250546
- Firm city
- Bowdoinham
- Firm state
- ME
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28