MoniTorr™ 10110Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780070849), received between Oct 2, 2023 and Jul 8, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K022554, K062599, K191684, K920156); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  A FACILITY REPORTED THAT THE PROXIMAL STOPCOCK ON THE CSF DRAINAGE SYSTEM (INS1100) BECAME LOOSE. THERE WAS NO APPARENT CRACKS IN THE TUBING AND COPIOUS AMOUNT OF CEREBROSPINAL FLUID (CSF) WAS OBSERVED ON THE PILLOW. ADDITIONAL INFORMATION RECEIVED: 1. WHAT IS THE LOT/SERIAL NUMBERS OF THE REPORTED DEVICE? UNKNOWN. 2. WHEN WAS PRODUCT PROBLEM DISCOVERED (DURING INSPECTION, BEFORE/DURING/AFTER A PROCEDURE)? WHILE IN USE WITH THE PATIENT. 3. WAS THERE A DELAY IN SURGERY DUE TO PRODUCT PROBLEM? IF YES, HOW LONG? NO, BUT THE PATIENT REQUIRED ANOTHER PROCEDURE TO REPLACE AN EVD AND A MONITORR. 4. FOR WHAT TYPE OF PROCEDURE WAS PRODUCT OR DEVICE USED? SUBARACHNOID HEMORRHAGE. 5. PATIENT FAMILY HAS CHOSEN TO DE-ESCALATE CARE, PATIENT REMAINS ALIVE AT THIS TIME.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 19697676 ↗
• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS INITIALLY REPORTED BY A FACILITY: "AIR FORFEITURE IN THE PATIENT LINE WITH GREEN STRIPE. AT CT CHECK ENCEPHALUS SHOWED THE PRESENCE OF PNEUMOVENTRICLE NOT VISIBLE AT PREVIOUS CHECK AND THEREFORE UNRELATED TO THE RECENT PLACEMENT OF THE SHUNT BUT PROBABLY TO THE DRAINAGE DM." ADDITIONAL INFORMATION WAS LATER RECEIVED INDICATING THE FOLLOWING: "NEUROSURGICAL PATIENT WAS ADMITTED ON (B)(6) 2023 FOR HEMORRHAGE SUBARACHNOID FROM RUPTURED ANEURYSM FOR WHICH SHE WAS PLACED IN ROOM. IN OPERATING ROOM, AN EXTERNAL VENTRICULAR SHUNT (DVE) REF.10110. ARRIVED FROM THE OPERATING ROOM TO THE INTENSIVE CARE UNIT. THE DVE WITH THE DRAINAGE AND MONITORING SYSTEM AND PROCEEDED TO DELIQUATION. THE EXTERNAL DRAINAGE AND MONITORING SYSTEM IS A CLOSED DESIGNED TO DRAIN THE CAFELORACHIDIAN FLUID (LCR) AND POSSIBLE BLOOD ALLOWING MONITORING OF INTRACRANIAL PRESSURE."

  Patient problems: Pneumocephalus

  MAUDE report 17851128 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022554, K062599, K191684, K920156. 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,
• 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