NA 44010Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169497108), received between Dec 7, 2016 and Jan 18, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 18, 2022Break; Break

  IT WAS REPORTED THAT DURING PREPARATION FOR THE SURGERY, THE DEVICE WAS FOUND TO BE BROKEN WHEN CHECKING THE INTEGRITY OF THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13285923 ↗
• MalfunctionJan 10, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A RESERVOIR ON (B)(6) 2020 DUE TO HYPERTENSIVE CEREBRAL HEMORRHAGE. DURING THE SURGERY, THE CONNECTING TUBE WAS BROKEN, AND THE DEVICE WAS REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9574940 ↗
• MalfunctionAug 5, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT INTRACRANIAL PRESSURE IMPLANTATION SURGERY. AFTER IMPLANTATION OF THE DEVICE, THE RESERVOIR SHOWED NO FLUID INFLOW, AND THE VENTRICLE WAS CIRCULATED SMOOTHLY. AFTER REPLACING THE RESERVOIR, IT WAS NORMAL. IT WAS NOTED THAT THIS RESULTED IN A 10 MINUTE PROCEDURE DELAY. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE - NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8861540 ↗
• MalfunctionJul 19, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT WAS TO HAVE BRAIN TUMOR SURGERY. DURING THE OPERATION, THE RESERVOIR WAS IMPLANTED; HOWEVER, THE VENTRICULAR TUBE BROKE AND WAS IMMEDIATELY REPLACED WITH ANOTHER DEVICE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

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

  MAUDE report 7704612 ↗
• MalfunctionMay 4, 2018Fracture; Fracture

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, IT WAS FOUND THAT THERE WAS A FRACTURE IN THE RESERVOIR. THE PORT WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7487979 ↗
• MalfunctionApr 20, 2018Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE LEAK WAS UNKNOWN, BUT IT WAS STATED THAT THERE MAY BE A LEAK IN THE RESERVOIR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7448123 ↗
• MalfunctionApr 5, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A TUMOR RESECTION FOR THE PATIENT, AND DURING THE OPERATION, THEY FOUND THAT THE DEVICE COULDN'T DRAIN CEREBROSPINAL FLUID NORMALLY. IT WAS STATED THAT THE SURGEON IMMEDIATELY REPLACED THE DEVICE WITH ANOTHER ONE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7400719 ↗
• MalfunctionAug 9, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE WAS LEAKING INTRA-OPERATIVELY, SO THEY STOPPED USING THE DEVICE IMMEDIATELY. ACCORDING TO THE REPORT, THE DEVICE WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6777525 ↗
• MalfunctionDec 7, 2016Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE RESERVOIR WAS FOUND TO BE CRACKED PRIOR TO USE. ACCORDING TO THE REPORT, THE DOCTOR REPLACED THE DEVICE WITH A NEW DEVICE TO COMPLETE THE SURGERY AND THE PATIENT WAS WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6151911 ↗