ICP Monitoring Device Recall: Potential Needle Corrosion in Codman Microsensor Kit
Integra LifeSciences is recalling the Codman Microsensor Basic Kit due to potential corrosion stains on the included 14-gauge Tuohy Needle. This device is used for intracranial pressure monitoring and corrosion could affect its function.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with no reported injuries or illnesses mentioned in the source. It qualifies as Score 3 (High) because it involves a risk-of-harm product—an intracranial pressure monitoring device where corrosion could affect reliability during critical patient care.
Plain-English summary
Integra LifeSciences Corp. is recalling 1,301 units of the Codman Microsensor Basic Kit (Catalog Number 626631US). The affected kit is distributed worldwide, including throughout the United States and multiple countries. The recall is related to specific lot numbers identified as having potential corrosion on the included needle.
The Codman Microsensor Basic Kit is a medical device used for direct intracranial pressure (ICP) monitoring in both subdural and intraparenchymal applications. The kit includes a 14-gauge Tuohy Needle that may have potential corrosion stains on its surface. Corrosion on the needle could compromise the device's ability to accurately measure intracranial pressure and affect patient monitoring.
The FDA has classified this as a Class II recall. Healthcare facilities that have received affected units should identify and quarantine them using the specific lot numbers provided. Integra LifeSciences should be contacted for replacement units or further instructions.
Patients or healthcare providers with questions about whether their device is affected should contact Integra LifeSciences with their device's lot number.
The recalled product
- Product
- Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Hazard
- corrosion
- device-defect
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 (20)
- Catalog Number: 626631US. UDI-DI: 10381780514473. Lot Numbers: 7288007
- 7288040
- 7294017
- 7305988
- 7305989
- 7305990
- 7305991
- 7307683
- 7325489
- 7336088
- 7336089
- 7336090
- 7305992
- 7346223
- 7391752
- 7391751
- 7406650
- 7406651
- 7406652
- 7408825
Distribution
Distributed nationwide across the United States.
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