Integra LifeSciences Corp.: 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.

Recall number

Z-1311-2019

Recalling firm

Integra LifeSciences Corp.

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 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.

Status

Terminated

Initiated

2019-04-08

Posted

2019-05-20

Terminated

2021-01-27

Reason

The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.

Root cause

Device Design

Action

On April 8, 2019, the firm distributed Urgent Medical Device Correction letters to its affected customers. The communication advised customers of the possible breakage of the stopcock. Customers were advised to take the following precautions: When connecting a fluid-filled transducer (FFT) to the Panel Mount/Transducer Mount stopcocks: " Do not apply excessive force while attaching the FFT to the stopcock. " Take care during the priming process to not torque or bend the syringe and FFT. " Ensure luer lock is "finger tight;" do not over-tighten connection at the stopcock junction. When managing an external ventricular or lumbar drain (EVD) with a FFT attached: " Take care when manipulating the stopcock to zero the FFT and to obtain pressure readings, do not apply excessive force to the stopcock junction. " Use caution during patient transportation and during routine ICU care, to avoid direct contact of the FFT with other devices or equipment. " If the FFT must be flushed or replaced, do not apply excessive torque or force to the FFT/ stopcock junction. " If the FFT is connected to the ICU bedside monitor, ensure the interface cable is positioned so that it does not place excess force on the FFT (e.Q. do not allow cable to touch the floor. Customers were asked to determine if they had any affected product on hand, review and understand the precautions, and complete and return a completed acknowledgement form to the firm. Distributors were asked to forward the customer letter to any customers who received the affected product. Should you have any questions regarding these instructions, please contact Customer Service Monday to Friday 8:00 AM - 8:00 PM EST USA: 1-800-654-2873: email: custsvcnj@integralife.com Outside USA: 781-565-1401 ***UPDATE*** On October 22, 2019, the firm sent out an updated notification informing customers that a new stopcock has been designed for the LimiTorr and MoniTorr, and is now available for replacement of th

Quantity

42102 units

Distribution

Worldwide Distribution - US Nationwide International distribution to Argentina, American Samoa, Australia, Canada, and Guam.

Lot, serial or model codes

All lots

510(k) numbers

["K022554","K062599"]

PMA numbers

not on file

Product code

JXG

Firm FEI

3003418325

Firm city

Plainsboro

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy