NA 48409Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00643169466319), received between Dec 15, 2016 and Apr 12, 2021 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2021Break; Break

  ADDITIONAL INFORMATION RECEIVED, REPORTED THAT 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 11649479 ↗
• MalfunctionOct 21, 2019Break; Break

  IT WAS REPORTED THAT A PIECE OF PLASTIC CAME OFF THE HANDLE OF A CATHETER PASSER WHILE TRYING TO REMOVE THE HANDLE DURING A CASE. THE PIECE WAS RETRIEVED, AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9216475 ↗
• MalfunctionJun 19, 2019Break; Break

  IT WAS REPORTED THE CATHETER PASSER WAS BROKEN. IT WAS STATED THEY TRIED TO RUN THE CATHETER THROUGH THE ALUMINUM PASSER BUT HAD NO LUCK. THE DOCTOR HAD TRIED TO ATTACH THE CATHETER PASSER ONTO THE INNER PLASTIC SLEEVE (WITHIN THE ALUMINUM PASSER), AND AS POSITIONING THE CATHETER ONTO THE CATHETER PASSER, THE SMALL PLASTIC SLEEVE BROKE (PART THAT CONNECTS THE CATHETER) WHICH MEANT THE SHUNT CATHETER COULD NOT BE CONNECTED TO THE CATHETER PASSER. THE DEVICE WAS REPLACED WITH ANOTHER ONE, AND THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THE PATIENT'S MEDICAL HISTORY WAS EPILEPTIC FITS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8713997 ↗
• MalfunctionOct 16, 2018Break; Break

  IT WAS REPORTED THAT UPON OPENING THE BOX, THE TIP AT WHERE THE CATHETER WAS BEING INSERTED WAS NOT PRESENT. A NEW BOX WAS OPENED TO COMPLETE THE VP SHUNT PROCEDURE. NO PATIENT DEATH OR INJURY OCCURRED. THE PATIENT'S CURRENT STATUS WAS OKAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7971451 ↗
• MalfunctionJan 3, 2018Break; Break

  IT WAS REPORTED PASSER TIP WAS BROKEN DURING THE PROCEDURE. THE PASSER WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7162335 ↗
• MalfunctionJan 3, 2018Break; Break

  IT WAS REPORTED PASSER TIP WAS BROKEN DURING THE PROCEDURE. THE PASSER WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7162304 ↗
• MalfunctionDec 21, 2017Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THE CATHETER PASSER BROKE OFF AT THE PLACE WHERE IT WAS INSERTED (JUST DISTAL TO) IN A GROOVE IN THE HANDLE. IT WAS THE PIECE OF THE PLASTIC THAT THE CATHETER ATTACHES TO THAT PULLS THE CATHETER THROUGH THE ROD. THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THERE WAS NO PATIENT INJURY, BUT THEY JUST HAD TO PASS THE CATHETER WITHOUT IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7138050 ↗
• InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE INFECTION WAS UNKNOWN. IT WAS ALSO STATED THE INFECTION WAS SEPSIS. THE CURRENT STATUS OF THE PATIENT WAS REPORTEDLY UNKNOWN.

  Patient problems: Inflammation; Sepsis; Staphylococcus Aureus

  MAUDE report 7108430 ↗
• InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE INFECTION WAS UNKNOWN. IT WAS ALSO STATED THE INFECTION WAS SEPSIS. THE CURRENT STATUS OF THE PATIENT WAS REPORTEDLY UNKNOWN.

  Patient problems: Inflammation; Sepsis; Staphylococcus Aureus

  MAUDE report 7108390 ↗
• MalfunctionSep 15, 2017Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT UPON OPENING THE DEVICE, THE SURGEON NOTICED THAT THE PROXIMAL TIP OF THE INNER PLASTIC CANNULA THAT ALLOWS THEM TO CONNECT THE CATHETER AND HELPS ASSIST PULLING IT THROUGH WAS BROKEN OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6868875 ↗
• InjuryJun 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT DEVELOPED AN INFECTION POST-OPERATIVELY. REPORTEDLY, THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: Unspecified Infection

  MAUDE report 6648367 ↗
• MalfunctionDec 15, 2016Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE TIP OF PASSER BROKE OFF INTRAOPERATIVELY. ACCORDING TO THE REPORT, THE TIP WAS NEVER FOUND AND IT IS UNKNOWN IF THE TIP REMAINS IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER PRODUCT AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6179128 ↗