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Strata™ 92866 (UDI 00643169976047)Recalls & reported problems

Medtronic Ps Medical, Inc. · VALVE 92866 FP STRATA 2 REG BG · Class 2 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169976047), received between Feb 12, 2019 and Jul 2, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K060681); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available1
  • Fluid/Blood Leak1
  • Infusion or Flow Problem1
  • Insufficient Device Problem Information1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1
  • Therapeutic Effects, Unexpected1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 2, 2021Infusion or Flow Problem; Infusion or Flow Problem

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12110283 ↗
  • InjuryDec 20, 2019Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT 20 DAYS AFTER IMPLANTATION, THE VALVE LEAKED AND THE PATIENT HAD SUBCUTANEOUS FLUID. THE VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER VALVE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-WITH INJURY.

    Patient problems: Therapeutic Effects, Unexpected

    MAUDE report 9505714 ↗
  • InjuryFeb 12, 2019Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT THE PHYSICIAN THOUGHT THAT THE ADJUSTMENT MECHANISM OF THE VALVE DID NOT WORK PROPERLY. THE ADJUSTMENT TOOL SHOWED A PLACE BETWEEN TWO PERFORMANCE LEVELS. IT WAS ALSO STATED THAT THE VALVE DID NOT DRAIN CEREBROSPINAL FLUID PROPERLY, AND THE PHYSICIAN SAID THAT THE VALVE WAS OCCLUDED. THE DEVICE WAS EXPLANTED. THE PATIENT'S MEDICAL HISTORY WAS OPERATED HYDROCEPHALUS, AND THEIR STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8330951 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060681. 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
  • Z-1121-2017 · Jan 17, 2017 · Terminated
    Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type valves are used in the management of hydrocephalus. The Strata

Other Shunt, central nervous system and components devices

All Shunt, central nervous system and components devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.