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Strata®, BioGlide® 27818Recalls & reported problems

Medtronic Ps Medical, Inc. · SHUNT 27818 STRATA II SML BIO · Class 2 · Implant

All models of Strata, BioGlide (8)

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

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 00643169010505), received between Dec 7, 2016 and Jun 8, 2018 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. 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
  • Leak/Splash1

Patient problems

  • No Known Impact Or Consequence To Patient2
  • Therapeutic Response, Decreased1

Recent adverse event reports

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

  • InjuryJun 8, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT AFTER THE VALVE WAS IMPLANTED, CEREBROSPINAL FLUID DID NOT FLOW NORMALLY. THE PRODUCTS WERE REPLACED WITHOUT ANY ISSUES AND THE PATIENT¿S STATUS WAS LISTED AS ALIVE ¿ NO INJURY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7584039 ↗
  • InjuryJun 28, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT HAD SHUNT SURGERY DUE TO HYDROCEPHALUS. ACCORDING TO THE REPORT, AFTER THE DEVICE WAS IMPLANTED, EXCESSIVE DRAINAGE OCCURRED ALONG WITH THE MAGNETIC RESONANCE IMAGING EXAMINATION SHOWED SMALL VENTRICLES. REPORTEDLY, THE DEVICE WAS REPLACED WITH ANOTHER ONE, AND THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

    Patient problems: Therapeutic Response, Decreased

    MAUDE report 6674195 ↗
  • MalfunctionDec 7, 2016Leak/Splash; Leak/Splash

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE CATHETER WAS FOUND TO BE LEAKING PRIOR TO USE. ACCORDING TO THE REPORT, THE DOCTOR USED A NEW DEVICE TO COMPLETE SURGERY. REPORTEDLY, THERE WAS NO INJURY TO THE PATIENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6153657 ↗

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 and updates

How reports and recalls are matched · Editorial policy · Report an error on this page