Catheter Passer 48409Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000027841), received between Dec 29, 2020 and Apr 20, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Break; Fracture; Difficult to Insert

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER PASSER. IT WAS REPORTED THAT THE DOCTOR ATTEMPTED TO USE THE CATHETER PASSER DURING A VENTRICULOPERITONEAL SHUNT PROCEDURE, AND THE SHAFT OF THE PASSER SEEMED TO BE MORE MALLEABLE THAN INTENDED. THE DOCTOR WAS UNABLE TO SUCCESSFULLY PASS THE CATHETER THROUGH THE CATHETER PASSER. IT WAS NOTED THE CATHETER PASSER WAS TOO DAMAGED TO BE RETURNED. THE DOCTOR USED A SOLID REUSABLE PASSER TO COMPLETE THE PROCEDURE. THIS RESULTED IN A PROCEDURE DELAY OF 5 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24928162 ↗
• MalfunctionApr 20, 2026Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER PASSER. IT WAS REPORTED THAT ON (B)(6), 2026, THE PATIENT ENTERED THE OPERATING ROOM AND UNDERWENT A VENTRICULOPERITONEAL SHUNT PROCEDURE UNDER GENERAL ANESTHESIA DUE TO HYDROCEPHALUS. THE DEVICE USED INTRAOPERATIVELY WAS A CEREBROSPINAL FLUID FLOW CONTROL SHUNT AND ACCESSORIES SET. A SINGLE-USE TUNNELING TOOL WAS USED TO CREATE A SUBCUTANEOUS TUNNEL. AFTER THE TUNNELING TOOL WAS WITHDRAWN, IT WAS FOUND THAT THE TIP OF THE INNER STYLET HAD FRACTURED, WITH A MISSING PORTION MEASURING APPROXIMATELY 3.3 MM × 3.3 MM. AFTER THE EVENT OCCURRED, THE OPERATOR IMMEDIATELY STOPPED THE PROCEDURE. THE SURGICAL TEAM CONDUCTED A CAREFUL SEARCH WITHIN THE OPERATIVE FIELD, USED C-ARM FLUOROSCOPY, AND REQUESTED AN ULTRASOUND CONSULTATION. THE LEAD SURGEON CONFIRMED THAT THE MISSING FRAGMENT WAS NOT PRESENT IN THE PATIENT¿S BODY. THE HEAD NURSE AND THE BIOMEDICAL ENGINEERING DEPARTMENT WERE NOTIFIED IMMEDIATELY. THE CONSUMABLE WAS COMPREHENSIVELY INSPECTED. THE LEAD SURGEON REPORTED THAT THE DEVICE WAS USED NORMALLY DURING THE PROCEDURE, WITH NO EXCESSIVE FORCE OR IMPROPER HANDLING. NO HARM WAS CAUSED TO THE PATIENT. IT WAS NOTED THAT THIS PROLONGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927926 ↗
• MalfunctionDec 11, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER PASSER. IT WAS REPORTED THAT THE TIP OF CATHETER PASSER, USED FOR RIGHT VENTRICU LOPERITONEAL SHUNT INSERTION WITH LAPAROSCOPIC ASSIST, BROKE OFF DURING TUNNELLING.  SURGEON WAS UNABLE TO TO LOCATE OR RETRIEVE IN PATIENT. THE TIP WAS NOT RADIOPAQUE SO X-RAY IMAGING WAS NOT HELPFUL IN RETRIEVAL. SURGEON DECIDED TO LEAVE MISSING PIECE IN-SITU.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23777099 ↗
• MalfunctionNov 12, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER PASSER. IT WAS REPORTED THAT THE PLASTIC TIP OF THE CATHETER PASSER BROKE OFF DURING TUNNELING OF A NEW PERITONEAL CATHETER DURING A SHUNT REVISION. THE TIP WAS UNABLE TO BE FOUND. IT WAS NOTED THAT THERE WAS POTENTIAL FOR PATIENT HARM.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23534246 ↗
• MalfunctionJun 24, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER PASSER. IT WAS REPORTED THAT THE ACORN TIP OF THE CATHETER PASSER BROKE OFF INSIDE THE PATIENT. IT WAS UNABLE TO BE LOCATED/REMOVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19594336 ↗
• InjuryAug 3, 2023Break; Fracture; Break; Fracture

  ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO OTHER REPORTED IMPACT TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17450487 ↗
• MalfunctionNov 14, 2022Break; Fracture; Break; Fracture

  ADDITIONAL INFORMATION RECEIVED: DELAY TO PROCEDURE WAS 10 MINUTES. THE PATIENT WAS OKAY AFTER PROCEDURE. THERE WAS NO REPORTED EVENT THAT OCCURRED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15793762 ↗
• MalfunctionDec 29, 2020Break; Break

  IT WAS REPORTED THAT THE THINNER PLASTIC PART BROKE EITHER WHEN PUTTING THE SHUNT CATHETER ON OR WHEN THE SHUNT CATHETER WAS ON AND USED INSIDE THE TUNNELING PASSER. THE DOCTOR STATED THAT IT TOOK SOME EXTRA TIME, APPROXIMATELY 3-5 MINUTES, TO SOLVE THE TUNNELING PROBLEM FOR THE ABDOMINAL PLACEMENT OF THE SHUNT CATHETER. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11088454 ↗
• MalfunctionDec 29, 2020Break; Break

  IT WAS REPORTED THAT THE THINNER PLASTIC PART BROKE EITHER WHEN PUTTING THE SHUNT CATHETER ON OR WHEN THE SHUNT CATHETER WAS ON AND USED INSIDE THE TUNNELING PASSER. THE DOCTOR STATED THAT IT TOOK SOME EXTRA TIME, APPROXIMATELY 3-5 MINUTES, TO SOLVE THE TUNNELING PROBLEM FOR THE ABDOMINAL PLACEMENT OF THE SHUNT CATHETER. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11088444 ↗
• MalfunctionDec 29, 2020Break; Break

  IT WAS REPORTED THAT THE THINNER PLASTIC PART BROKE EITHER WHEN PUTTING THE SHUNT CATHETER ON OR WHEN THE SHUNT CATHETER WAS ON AND USED INSIDE THE TUNNELING PASSER. THE DOCTOR STATED THAT IT TOOK SOME EXTRA TIME, APPROXIMATELY 3-5 MINUTES, TO SOLVE THE TUNNELING PROBLEM FOR THE ABDOMINAL PLACEMENT OF THE SHUNT CATHETER. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11088386 ↗
• MalfunctionDec 29, 2020Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11088358 ↗