MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount… — Class I medical device recall Z-1311-2019
Terminated recall by Integra LifeSciences Corp., reported 2019-05-29, distributed nationwide. The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and Mon
| Recall number | Z-1311-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2019-04-08 |
| Classified | 2019-05-20 |
| Reported by FDA | 2019-05-29 |
| Terminated | 2021-01-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, CA |
| Quantity | 42,102 units |
| Reason classes | device malfunction |
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.
Reason for recall
The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.