Integra MoniTorr CSF Drainage System Recalled for Stopcock Breakage
Integra LifeSciences is recalling MoniTorr CSF Drainage Systems due to a complaint trend regarding stopcock breakage.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock."
Plain-English summary
Integra LifeSciences Corp. is recalling the MoniTorr INS1100 CSF Drainage System used with a Pole Mount System. The recall involves 42,102 units distributed worldwide, including the United States, Argentina, American Samoa, Australia, Canada, and Guam. The product is a closed system used for the drainage and monitoring of cerebrospinal fluid (CSF) from the brain or lumbar subarachnoid space to reduce intracranial pressure.
The firm identified a complaint trend regarding the breakage of the LimiTorr Transducer Mount stopcock and the MoniTorr Panel Mount stopcock. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Healthcare providers and patients should contact Integra LifeSciences Corp. for further instructions on how to handle the affected devices.
The recalled product
- Product
- MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage: The MoniTorr ICP External CSF Drainage and Monitoring Systems provide a simple to use, closed system for the drainage of cerebrospinal fluid (CSF) from ventricles of the brain or the…
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 42,102
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 (1)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Integra LifeSciences Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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