Use cautionMedical device recall · FDA · Published April 8, 2019
Integra MoniTorr INS1100 CSF Drainage System Recall: Stop Using Due to Breakage Risk
Integra LifeSciences recalls MoniTorr INS1100 CSF Drainage Systems used with Pole Mount System due to reported breakage of transducer mount stopcocks. Affected patients should stop using the device immediately.
“Integra MoniTorr INS1100 CSF Drainage System Recall: Stop Using Due to Breakage Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68418-integra-monitorr-ins1100-csf-drainage-system-recall-stop-using-due. Based on FDA recall #Z-1311-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1311-2019%22&limit=1).
Integra LifeSciences Corp. recalled the MoniTorr INS1100 INS-1100 CSF Drainage System on April 8, 2019, due to stopcock breakage hazards, according to the FDA. The firm initiated this voluntary Class I recall affecting 42,102 units distributed worldwide.
How to tell if you have it
Brand: Integra LifeSciences
Product: MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System
Quantity: 42,102 units
The hazard
The FDA said the firm identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock. The recall record does not report specific incidents or injuries.
Context
GovInfoNow's records show Integra LifeSciences Corp. has 35 other recalls on record since Aug. 18, 2017. Recent brand recalls include the AURORA Surgiscope System (Feb. 6, 2025), MediHoney Wound Dressing Gel (Jan. 10, 2025), and CODMAN CERTAS Plus Valve (Dec. 16, 2024). Other recent recalls of similar products include the Codman CerebroFlo EVD Catheter (April 10, 2026), Codman CereLink ICP Sensor Basic Kit (Dec. 12, 2025), and Nipro Medical Hemodialysis System Surdial DX (Oct. 27, 2025).
How to tell if you have this one
Check for the MoniTorr INS1100 CSF Drainage System with Pole Mount System. The product is used for cerebrospinal fluid drainage and has been sold to patients needing brain or spinal fluid monitoring.
Brand
Integra LifeSciences
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Terminated
Distribution
Worldwide Distribution - US Nationwide International distribution to Argentina, American Samoa, Australia, Canada, and Guam.
Recall number
Product, codes & lots
Z-1310-2019
MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniTorr 10102 10-102 CSF Drainage System w/Patient Line One Way Valve w MoniTorr 10110 10-110 CSF Drainage System used with Pole Mount System MoniTorr 10140 10-140 CSF Drainage System w/Vinyl Measuring Strip MoniTorr 10150 10-150 CSF Drainage System Simple Bag and Line MoniTorr 10110A 10-110A CSF Drainage System w/o Manifold Stopcock MoniTorr SP0017 SP0017 Special EVD 10-110 w/o Y Site Latex Free Sites MoniTorr SP0042 SP0042 Special EVD 10-100 w/o Y Site MoniTorr SP0090 SP0090 Special EVD 10-110 w/o Y Site MoniTorr SP0164 SP0164 Special EVD 10-140 w/Y Site & Stopcock Reverse MoniTorr SP0236 SP0236 INS 1100 WITH NEEDLE AT Y-ACCESS AND NEEDLELESS SI 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 lumbar subarachnoid space to a drainage bag. The system may be used with a pole mounted assembly that allows for simple, quick and accurate alignment with the patient and secure positive or negative pressure level setting. The system also has been designed to provide for ease of patient transport through a compact design and antimicrobial hydrophobic vent feature that resists occlusion. Indications: The MoniTorr ICP system allows for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF inpatients with infected CSF shunts, and to monitor ICP.; All lots
Z-1311-2019
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 lumbar subarachnoid space to a drainage bag. The system may be used with a pole mounted assembly that allows for simple, quick and accurate alignment with the patient and secure positive or negative pressure level setting. The system also has been designed to provide for ease of patient transport through a compact design and antimicrobial hydrophobic vent feature that resists occlusion. Indications: The MoniTorr ICP system allows for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF inpatients with infected CSF shunts, and to monitor ICP.; All lots
Z-1312-2019
LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS9020SP1 INS-9020SP1 LIMITORR VOLUME EVD 20ML LimiTorr INS9030 INS-9030 LIMITORR VOLUME LIMITING EVD 30 ML LimiTorr INS9030SP1 INS-9030SP1 LIMITORR VOLUME LIMITING EVD 30 ML Product Usage: The LimiTorr External CSF Drainage and Monitoring Systems provides a closed system for the CSF from the ventricles of the brain or the lumbar subarachnoid space to an external drainage bag. The LimiTorr volume limiting external CSF drainage system was designed to include a volume limiting valve mechanism which reduces the chances for excessive CSF drainage. The burette in the volume limiting external CSF drainage system contains a volume limiting valve which stops drainage when the pre-determined volume (20ml-30ml) is reached. Indications: The LimiTorr system allows for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and to monitor ICP.; All lots
Based on the official FDA remedy
What to do — step by step
Stop Using Immediately
The MoniTorr INS1100 CSF Drainage System with Pole Mount System should be stopped using immediately due to reported breakage risks.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide Distribution - US Nationwide International distribution to Argentina, American Samoa, Australia, Canada, and Guam.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1311-2019 (April 8, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1311-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.