Strata®, BioGlide® 92856Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169010420), received between Oct 10, 2017 and Mar 14, 2018 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 reports).

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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 14, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT AFTER THE PROCEDURE WAS COMPLETED, NO CHANGE IN INTRACRANIAL PRESSURE WAS OBSERVED. THE DEVICE WAS REPLACED BY ANOTHER DEVICE.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 7338927 ↗
• MalfunctionMar 1, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE SURGEON CONNECTED THE VALVE TO THE PROXIMAL AND DISTAL CATHETERS AND QUESTIONED WHETHER IT WAS WORKING WHEN PUMPING THE RESERVOIR. THE VALVE WAS REPLACED DURING THE SAME SURGERY. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7308766 ↗
• InjuryDec 1, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THAT THE DEVICE WAS OCCLUDED AND EXPLANTED. THE PATIENT'S CURRENT STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 7075438 ↗
• InjuryOct 10, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DEVICE WAS REPLACED THE DAY PRIOR BECAUSE FOR THE LAST APPROXIMATELY 18 MONTHS, THE DEVICE'S PRESSURE SETTING HAD CHANGED SPONTANEOUSLY 3 TIMES. IT WAS NOTED THE PATIENT WAS IMPLANTED FOR CEREBRAL PARES AND HYDROCEPHALUS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6937609 ↗

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