MoniTorr™ INS1100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780071037), received between Jun 14, 2024 and Jun 14, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K022554, K062599, K191684); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A FACILITY REPORTED THE FOLLOWING OCCURRED WHILE THE CSF DRAINAGE SYSTEM USED WITH POLE MOUNT SYSTEM (INS1100) WAS IN USE: ¿WHILE IN CT, PATIENT'S EVD TUBING SPONTANEOUSLY POPPED A HOLE AND CSF BEGAN TO SQUIRT OUT OF TUBING. TUBING HAD PLENTY OF SLACK AND THE PATIENT WAS NOT BEING MOVED AT THE TIME OF THE INCIDENT. WRITER CLAMPED EVD, BUT CSF WAS STILL LEAKING FROM THE HOLE SO WRITER TAPED THE HOLE. NOTIFIED NEURO ICU PA AND NEUROSURGERY PA WHO SAID TO CLAMP IT PROXIMALLY AND THE SYSTEM WOULD HAVE TO BE REPLACED. EVD SYSTEM WAS LATER REPLACED DURING DAYSHIFT.¿ SUBSEQUENT INFORMATION WAS ALSO REPORTED AS FOLLOWS: 1. PLEASE PROVIDE PATIENT'S GENDER, ETHNICITY, AND RACE. >> MALE, HISPANIC. 2. WAS THERE A DELAY IN SURGERY DUE TO PRODUCT PROBLEM? IF YES, HOW LONG? >> NONE REPORTED. 3. WHAT IS THE LOT/SERIAL NUMBERS OF THE REPORTED DEVICES? >> UNKNOWN, DEFECTIVE PRODUCT WAS DISCARDED. 4. HOW MUCH CSF LEAKED DURING THE INCIDENT (IF AN EXACT AMOUNT CANNOT BE PROVIDED, PLEASE PROVIDE AN APPROXIMATE: SMALL AMOUNT, MODERATE, ETC.)? >> SMALL/MODERATE AMOUNT. 5. PLEASE PROVIDE PATIENT OUTCOME, OR STATUS OF THE PATIENT. >> STABILIZED AND REPLACED WITH A NEW SYSTEM DURING THE DAYSHIFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19539253 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022554, K062599, K191684. One submission often covers many models, so check the product and lot details in each record.

• Z-1311-2019 · Apr 8, 2019 · Terminated
  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, cl
• Z-1310-2019 · Apr 8, 2019 · Terminated
  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 S