CAMINO® 110-4HMT (UDI 10381780025528)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780025528), received between Jan 29, 2018 and Aug 14, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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

• MalfunctionAug 14, 2019Output Problem; Output Problem

  CATHETER STOPPED WORKING AFTER IMPLANTATION ONCE CUSTOMER WAS TRANSPORTED FROM OR TO ICU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8894067 ↗
• MalfunctionJan 29, 2018Break; Difficult to Remove; Device Operational Issue; Material Integrity Problem; Device Operational Issue; Material Integrity Problem

  FROM INITIAL "COMMUNICATING COMPLAINT INFORMATION" FORM RECEIVED BY NATUS ON (B)(6) 2018: "DEVICE IN CONTACT WITH PATIENT: NO." "PATIENT INJURY/ DEATH ALLEGED: NO." "REVISION/MEDICAL INTERVENTION REQUIRED: NO." "PATIENT PREPPED FOR SURGERY: NO." "PATIENT INFORMATION: AGE_(B)(6), GENDER: MALE". "DELAY IN SURGERY DUE TO LATE RECEIPT OF PRODUCT: NO." "DELAY IN SURGERY DUE TO PRODUCT PROBLEM: NO." "OUT OF BOX FAILURE(OOB): NO." "BEFORE THE SURGICAL PROCEDURE, THE RESPECTIVE COUPLINGS ARE PERFORMED (ELECTRIC CURRENT, PAC-1 CABLE), THE MONITOR IS TURNED ON WITHOUT ENCOUNTERING ANY DIFFICULTY OR INCONSISTENCY, THE SURGERY IS INITIATED, THE INCISION IS MADE, AND THE TREPANNING OF THE SKULL IS PERFORMED. MOMENT OF ENTERING THE VENTRICULAR CATHETER WITH ITS RESPECTIVE SCREW, IT IS FIXED TO THE SKULL, IT IS TIED TO THE CATHETER SYSTEM, WE CONTINUE WITH THE PROCEDURE BUT WHEN TO REMOVE THE GUIDE IT DID NOT ALLOW IT TO LEAVE THE CATHETER, IT IS REMOVED FROM THE PATIENT THE CATHETER TOGETHER WITH THE SCREW TO VERIFY IF THE GUIDE CAN BE REMOVED, IT IS INTRODUCED AGAIN AND THE PATIENT IS NOT DRAINED, IT IS REMOVED AND REINTRODUCED A THIRD TIME, THE SCREW IS ADJUSTED BUT THE GUIDE DOES NOT COME OUT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7226646 ↗