microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode o
Summary
The FDA issued a Class I for microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use i by FHC, Inc.. Reason: A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too.
Details
Source
Device Recall
External ID
Z-0312-2025
Action Date
2024-11-20
Status
Ongoing
Category
device
Product Description
microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.
Lot/Code Info: Package DI: 10873263004323; Contains DI Package: 00873263004326 LOT No. 244517
Quantity Affected: 8 packs of 5ea (40 total)
Reason for Recall
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.
Distribution
Domestic distribution only to the following states: AZ, CA, PA, TN, TX, WA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-04
Company
Bowdoin, ME
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 242 device recalls issued in the same week, part of 403 device-related FDA actions this month.
FHC, Inc. has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (FHC, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does FHC, Inc. have FDA actions?
FHC, Inc. has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0312-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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