N/A 46419 (UDI 00763000027285)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000027285), received between Oct 13, 2022 and Jun 3, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THE CATHETER HAD NO FUNCTION AND WAS DAMAGED. IT WAS NOTED THAT THE CATHETER WAS NEVER IMPLANTED. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25375009 ↗
• InjuryApr 3, 2026Break; Fracture

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RETURNED TO THE OPERATING ROOM FOR REMOVAL OF BROKEN CATHETER BUT WAS DOING OKAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24774227 ↗
• MalfunctionOct 21, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING LUMBAR CATHETER. IT WAS REPORTED THAT THE CATHETER BROKE DURING THE FIRST ATTEMPT OF INSERTION. APPROXIMATELY 1 CM OF THE CATHETER REMAINED IN THE PATIENT. THE BROKE PIECES WERE RETRIEVED, AND THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347163 ↗
• MalfunctionAug 26, 2025Break; Fracture; Difficult to Insert; Break; Fracture; Difficult to Insert

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT DURING AN EMERGENCY LUMBAR DRAIN INSERTION, AFTER INSERTION OF THE TROCAR AND CONFIRMATION OF CEREBROSPINAL FLUID (CSF) DRAINAGE, THE LUMBAR DRAIN CATHETER WAS INTRODUCED. RESISTANCE WAS FELT DURING INSERTION, AND THE TROCAR WAS REPOSITIONED. ON THE SECOND ATTEMPT, RESISTANCE WAS STILL PRESENT, AND A GUIDE WIRE WAS USED. DESPITE THIS, RESISTANCE PERSISTED, AND UPON WITHDRAWAL, IT WAS OBSERVED THAT THE LUMBAR DRAIN CATHETER HAD FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893320 ↗
• MalfunctionNov 5, 2024

  LUMBAR DRAIN WAS ATTEMPTED TO BE INSERTED. UPON REMOVAL OF LUMBAR DRAIN, TIP WAS NOTED TO NOT BE INTACT. THE LUMBAR DRAIN TIP RETAINED IN EPIDURAL SPACE REQUIRING URGENT LAMINECTOMY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20609134 ↗
• MalfunctionOct 13, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A LUMBAR CATHETER. IT WAS REPORTED THE CATHETER SNAPPED WHILE BEING INSERTED INTO THE PATIENTS LUMBAR SPACE. IT WAS REPORTED THAT PIECES WERE LEFT IN THE PATIENT. THE SURGEON WAS ABLE TO OPEN A DIFFERENT CATHETER OF THE SAME LOT NUMBER AND IT DID NOT BREAK EVEN THOUGH THE FIRST TWO DID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15595078 ↗
• MalfunctionOct 13, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A LUMBAR CATHETER. IT WAS REPORTED THE CATHETER SNAPPED WHILE BEING INSERTED INTO THE PATIENTS LUMBAR SPACE. IT WAS REPORTED THAT PIECES WERE LEFT IN THE PATIENT. THE SURGEON WAS ABLE TO OPEN A DIFFERENT CATHETER OF THE SAME LOT NUMBER AND IT DID NOT BREAK EVEN THOUGH THE FIRST TWO DID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15595048 ↗