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Strata™ 42836 (UDI 00643169975811)Recalls & reported problems

Medtronic Ps Medical, Inc. · VALVE 42836 STRATA II BURR HOLE · Class 2 · Implant

All models of Strata (53)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169975811), received between Jan 9, 2018 and Sep 24, 2018 — classified as 2 injuries.

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 (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

Device problems

  • Appropriate Device Problem Term/Code Not Available1
  • Device Operates Differently Than Expected1
  • Insufficient Device Problem Information1

Patient problems

  • Therapeutic Effects, Unexpected1
  • Therapeutic Response, Decreased1

Recent adverse event reports

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

  • InjurySep 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PHYSICIAN WAS WONDERING IF THE VALVE COULDN'T PERFORM WELL DUE TO THE PATIENT'S BRAIN PRESSURE BEING TOO HIGH.

    Patient problems: Therapeutic Effects, Unexpected

    MAUDE report 7901693 ↗
  • InjuryJan 9, 2018Device Operates Differently Than Expected; Appropriate Device Problem Term/Code Not Available; Device Operates Differently Than Expected; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THE PATIENT¿S UNDERLYING DISEASE SYMPTOMS WERE NOT IMPROVED. A SHUNT ANGIOGRAM WAS PERFORMED AND OCCLUSION WAS SUSPECTED. CEREBROSPINAL FLUID (CSF) DID NOT FLOW FROM THE VALVE TO THE ABDOMINAL CATHETER. ALTHOUGH THE PERFORMANCE LEVEL WAS SET TO 0.5, THE CSF DID NOT FLOW WITHOUT APPLYING THE PRESSURE 10 CM. THE VALVE WAS REPLACED. IT WAS STATED THERE WAS A MALFUNCTION OF THE ¿VARIANT PART¿ OF THE VALVE.

    Patient problems: Therapeutic Response, Decreased

    MAUDE report 7176213 ↗

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

Other Shunt, central nervous system and components devices

All Shunt, central nervous system and components devices →

Sources and updates

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