StrataMR 42965MRRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000422714), received between Sep 10, 2024 and Aug 12, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2025Mechanical Jam; Mechanics Altered; Mechanical Jam; Mechanics Altered

  MEDTRONIC RECEIVED INFORMATION REGARDING A MAGNETIC RESISTANT ADJUSTABLE VALVE. IT WAS REPORTED THE VALVE CHANGED FROM 2.0 TO 2.5 AFTER GOING THROUGH AN MRI, BUT THEN WHEN THE CUSTOMER WENT TO ADJUST THE SETTING, THEY WERE ONLY ABLE TO DO SO ON THE 11TH ATTEMPT, AND IT COULD ONLY GO FROM 2.5 TO 2.0 AND THE MAGNET HAD TO SIT DIRECTLY OVER THE VALVE. THE DEVICE WAS REPLACED WITH A NON MAGNETIC ADJUSTABLE VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790535 ↗
• InjurySep 10, 2024Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THE PATIENT'S VALVE WAS SET TO 0.5, BUT THEY WERE NOT DRAINING ENOUGH/INSUFFICIENTLY. THE PATIENT CAME INTO THE HOSPITAL, AND CT SHOWED ACUTE HYDROCEPHALUS. THE VENTRICLES WERE REFILLED TO A HIGH PRESSURE. THE SITE DID NOT OBSERVE ANY FLAWS IN THE CATHETERS WHEN THEY EXPLAINED THEM, AND THE RESERVOIR ON THE VALVE WAS SOFT ENOUGH TO PUSH DOWN MEANING IT WAS NOT OBSTRUCTED WHEN THEY PALPATED IT BEFORE THE VALVE WAS EXPLANTED. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE WAS THERE WHEN THEY IMPLANTED IT, AND IT WAS UNDER AXIEM NAVIGATION. THEY HAD IMMEDIATE CEREBROSPINAL FLUID FLOW AFTER PLACED THE VENTRICULAR CATHETER. THE SITE DID NOT DO A CHEST ABDOMEN CT TO SEE IF THE PERITONEAL CATHETER WAS KINKED. WHEN EXPLANTING, THE SURGEON SAID THEY FLUSHED SALINE INTO THE PERITONEAL CATHETER WITHOUT RESISTANCE. AN EXTERNAL VENTRICULAR DRAIN WAS PLACED WHICH DRAINED THE PATIENT ADEQUATELY WITH AN INTRACRANIAL PRESSURE RANGING FROM 2-10. THE VALVE SETTING WAS CONFIRMED WITH THE REPORTED DEVICE HAND TOOLS OF 0.5. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20184383 ↗