Strata® 42836Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994380098), received between Dec 29, 2016 and Jul 28, 2023 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K083076); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2023Mechanics Altered; Mechanics Altered

  MEDTRONIC RECEIVED INFORMATION REGARDING A STRATA VALVE. IT WAS REPORTED THAT THERE WAS AN ISSUE WIT THE STRATA VALVE ADJUSTMENT. THERE WAS A PATIENT THAT HAD A HYDROCEPHALUS VALVE PLACED IN (B)(6) 2019. FOR THE PAST 12 MONTHS THIS VALVE HAS NOT MAINTAINED THE PROGRAMMED SETTINGS NEEDED WHEN ALTERATIONS MADE TO DRAIN CEREBROSPINAL FLUID. AS A RESULT THE PATIENT HAD ANOTHER VALVE AND SURGICAL PROCEDURE TO REPLACE THIS FAULTY VALVE. A DEVICE FROM ANOTHER MANUFACTURER WAS USED TO REPLACE THIS ONE ONCE REMOVED. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17412930 ↗
• InjuryMar 6, 2020Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT THE PATIENT'S SHUNT HAD BEEN TURNING OFF AND ON, ON ITS OWN. IT WAS CLARIFIED THAT THE SETTINGS HAD BEEN CHANGING. THE PATIENT HAD BEEN EXPERIENCING ISSUES WITH THEIR BALANCE AND GAIT. THEY HAD ALSO EXPERIENCED SOME PASSING OUT AS WELL.

  Patient problems: Ambulation or Postural Difficulties; Loss of consciousness

  MAUDE report 9801325 ↗
• InjuryJul 29, 2019Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THE VALVE WAS EXPLANTED DUE TO THE VALVE SETTING RANDOMLY CHANGING. THERE WAS NO MAGNETIC INFLUENCE PRESENT WHEN THE VALVE SETTING WAS CHANGING. THE PATIENT HAD BEEN DOING FINE SINCE THE NEW VALVE WAS IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8837973 ↗
• MalfunctionAug 1, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT ON (B)(6) 2017, A LEAK WAS DISCOVERED IN THE DEVICE DURING THE IMPLANT PROCEDURE. ACCORDING TO THE REPORT, THE DEVICE WAS REMOVED AND REPLACED WITH A NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6758499 ↗
• MalfunctionDec 29, 2016Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT WATER DID NOT FLOW TO THE ABDOMINAL SIDE, IN SPITE OF PUMPING/PRIMING PRE-OPERATIVELY. ACCORDING TO THE REPORT, THE PRODUCT WAS REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6214522 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083076. One submission often covers many models, so check the product and lot details in each record.

• Z-1116-2021 · Jan 11, 2021 · Open, Classified
  Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: 27739 - SHUNT 27739 STRATA NSC SNAP SML 120CM, 27740 - SHU