CAMINO® 110-4BT (UDI 10381780023630)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10381780023630), received between Nov 16, 2017 and Dec 20, 2019 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Output Problem” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2019Output Problem; Output Problem

  IMPLANTED CATHETER HAS FAILED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9504687 ↗
• InjuryNov 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  CATHETER DETACHED DURING PROCEDURE, LEAVING A PART BEHIND IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9355047 ↗
• MalfunctionSep 4, 2019Output Problem; Output Problem

  CATHETER GAVE HIGH READINGS COMPARED TO EVD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8962508 ↗
• MalfunctionApr 19, 2018Unable to Obtain Readings; Device Issue; Unable to Obtain Readings; Device Issue

  THE FOLLOWING WAS REPORTED BY A FOREIGN USER FACILITY: "THE HOSPITAL INFORMED THE CATHETER STOPPED THE MEASUREMENT DURING THE USE." NO PATIENT INJURY, CONCLUDED WITH ANOTHER CATHETER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7444858 ↗
• MalfunctionNov 16, 2017Unable to Obtain Readings; Unable to Obtain Readings

  THE INITIAL REPORTER SUBMITTED THE FOLLOWING 13 DEC 2017 IN RESPONSE TO AN E-MAIL REQUESTING FURTHER EVENT DETAILS: "WAS THERE ANY INJURY TO THE PATIENT? NO" "WAS ANY MEDICAL INTERVENTION REQUIRED? NO" "WAS THERE A DELAY IN SURGERY CAUSED BY THE PRODUCT ISSUE? NO" "PATIENT: AGE (B)(6)" "GENDER: MALE" "WEIGHT (B)(6)" "DATE CATHETER WAS PLACED, IF APPLICABLE: (B)(6) 2017" "DATE THE CATHETER WAS REMOVED, IF APPLICABLE: (B)(6) 2017" "WAS A USER FACILITY REPORT SUBMITTED TO FDA? NO" UPON REQUEST FOR FURTHER DETAILS FROM THE INITIAL REPORTER, THE FOLLOWING WAS RECEIVED 17 JAN 2018: "OPERATOR OF DEVICE" OR, WHO WAS USING IT WHEN THE MALFUNCTION OR INJURY WAS OBSERVED? (BY PROFESSION SUCH AS "PHYSICIAN", MED TECH, ETC.) PHYSICIAN SND NURSE"

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7038050 ↗