Strata™ 42836 (UDI 00763000031237)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000031237), received between May 24, 2021 and May 31, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 31, 2024Infusion or Flow Problem; Mechanics Altered; Insufficient Device Problem Information; Infusion or Flow Problem; Mechanics Altered; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A HISTORY OF DEPRESSION, AND ANXIETY WHO COMPLAINED OF HEADACHE STARTING APPROXIMATELY 1 YEAR AGO, MIGRAINE TYPE WHICH PROGRESSIVELY GOTTEN WORSE AND ASSOCIATED WITH VISUAL CHANGES. LUMBAR PUNCTURE WAS PERFORMED ROUGHLY ABOUT 4 TIMES WITH VERY HIGH PRESSURE ON MULTIPLE OCCASIONS. PATIENT WAS DIAGNOSED WITH BENIGN INTRACRANIAL PRESSURE. MEDICAL TREATMENT WAS STARTED BUT WITHOUT IMPROVEMENT IN SYMPTOMS. THE PATIENT UNDERWENT RIGHT VENTRICULOPERITONEAL (VP) SHUNT PLACEMENT ON (B)(6) 2023 AND WAS SET AT 2.0. THE PATIENT WAS DISCHARGE ON (B)(6)2023. ON (B)(6), THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH HOSPITAL ADMISSION DUE TO INTRACTABLE HEADACHE PREDOMINATELY ON THE RIGHT SIDE AND WAS PRESENT PRIOR TO WHEN THEY WERE DISCHARGED WITH NO IMPROVEMENT AT HOME DESPITE PAIN MEDICATION WITH CONCERNS REGARDING INCREASING VENTRICULAR SIZE ON CT IMAGING IN THE SETTING OF PSEUDOTUMOR CEREBRI STATUS POST VP SHUNT. IT WAS NOTED THE PATIENT HAD AN ABDOMINAL RASH LIKELY CONTACT DERMATITIS SECONDARY TO REACTION TO THE ADHESIVE FROM THE WOUND DRESSING FOLLOWING VP SHUNT CREATION, DOUBT INFECTION AT THAT TIME. THE PATIENT'S SHUNT

  Patient problems: Diarrhea; Discomfort; Dizziness; Headache; Hematuria; Irritability; Nausea; Neck Pain; No Clinical Signs, Symptoms or Conditions; Sleep Dysfunction; Vomiting

  MAUDE report 19434023 ↗
• InjuryMay 24, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER THE PROCEDURE, THE PATIENT'S PRESSURE WAS CHANGED 2 TIMES; HOWEVER, THE SHUNT WAS NOT WORKING, AND THE PATIENT'S STATUS WAS STILL THE SAME. AS A RESULT, THE VALVE WAS REPLACED WITH A FIXED PRESSURE VALVE. THE REPLACEMENT VALVE WORKED PERFECTLY, AND THE PATIENT WAS MUCH BETTER.

  Patient problems: Insufficient Information

  MAUDE report 11871648 ↗

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