StrataMR 46955Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169593442), received between Mar 10, 2017 and Apr 5, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

1 other recall cover devices cleared under the same FDA submission (K152700); they may or may not involve this specific model.

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.

• MalfunctionApr 5, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT AT FIRST, THE PHYSICIAN THOUGHT THERE WAS SOMETHING WRONG WITH THE PRESSURE ADJUSTMENT. ACCORDING TO THE REPORT, THE ANGLE OF THE REPORTED VALVE WAS DIFFERENT FROM THE ANGLE OF ANOTHER VALVE. WHEN THE DOCTOR CHECKED THE ANGLE, THEY SUSPECTED A MALFUNCTION OF THE SETTING. REPORTEDLY, THE MANUFACTURER REPRESENTATIVE PROVIDED INFORMATION FOR SETTING THE PRESSURE AND THE DOCTOR WAS ABLE TO CONFIRM THE SETTING. THE PRESSURE SETTING WAS ABLE TO BE ADJUSTED AND THE DEVICE REMAINED IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6461805 ↗
• InjuryMar 10, 2017Mechanical Jam; Mechanical Jam

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PRESSURE SETTING COULD NOT BE CHANGED. ACCORDING TO THE REPORT, AN ANOMALY OF THE PART FOR PRESSURE ADJUSTMENT WAS SUSPECTED. IT WAS STATED THAT OVERDRAINAGE WAS PREVENTED BY THE PATIENT KEEPING THEIR HEAD UP. REPORTEDLY, THE DEVICE WAS EXPLANTED.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6395323 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152700. One submission often covers many models, so check the product and lot details in each record.

• Z-1702-2017 · Feb 22, 2017 · Terminated
  The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the