FHC microTargeting Insertion Tube Set Recalled for Spacer Defect
FHC, Inc. recalls microTargeting Insertion Tube Set Lot 244517, affecting 40 units distributed domestically. The oversized spacer tube component risks intracranial hemorrhaging during neurosurgical procedures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a neurosurgical device with potential for intracranial hemorrhaging and brain damage. Although no reported injuries exist, FDA Class I classification requires a minimum score of 4, resulting in a Severe rating.
Plain-English summary
FHC, Inc. is recalling microTargeting Insertion Tube Set, Lot 244517. This medical device is used during stereotactic functional neurosurgical procedures to accurately guide a microelectrode or instrument in the brain. The recall affects 40 units (eight 5-unit packs) distributed to hospitals and surgical centers in Arizona, California, Pennsylvania, Tennessee, Texas, and Washington.
An FDA investigation, triggered by a customer complaint, discovered that the spacer tube component in this lot was manufactured to an incorrect schematic—the tube is too long relative to other components of the device. Using the device with an oversized spacer tube during surgery could result in intracranial hemorrhaging and brain damage.
Healthcare facilities that received this lot should immediately discontinue use and remove the affected units from service. Contact FHC, Inc. to arrange return or disposal, and report any incidents or adverse events to both the manufacturer and the FDA. This is a Class I recall, the agency's highest classification for medical device recalls.
The recalled product
- Product
- 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.
- Manufacturer
- FHC, Inc.
- Hazard
- assembly-defect
- intracranial-hemorrhage
- brain-damage
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 (2)
- Package DI: 10873263004323
- Contains DI Package: 00873263004326 LOT No. 244517
Distribution
Distributed in 6 states:
- AZ
- CA
- PA
- TN
- TX
- WA
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