Strata®, BioGlide® 92866Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169010413), received between May 2, 2017 and Nov 15, 2017 — classified as 3 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryNov 15, 2017Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT ALTHOUGH THE EVENT MIGHT HAVE BEEN RELATED TO LOW INTRACRANIAL PRESSURE, CEREBROSPINAL FLUID (CSF) DID NOT FLOW NORMALLY. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 7035564 ↗
• InjuryJun 6, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A SURGEON WAS UNDER THE IMPRESSION THAT A SHUNT PATIENT OF THEIRS MAY BE EXPERIENCING REVERSE POLARITY. THE PATIENT WAS IMPLANTED IN (B)(6) 2017, AND A MARCH CT SCAN SHOWED OVER DRAINAGE AT A SETTING OF 2.0. THE SETTINGS WERE THEN ADJUSTED TO 2.5 TO DECREASE DRAINAGE. ACCORDING TO THE REPORT, THE SURGEON SENT PICTURES OF AN X-RAY OF THE VALVE TO A DESIGN ENGINEER AT MEDTRONIC, BUT THE PICTURE WAS INVERTED. THE SURGEON THEN PULLED UP THE X-RAY EXAM ON A MONITOR IN THE OPERATING ROOM (OR) AND A PICTURE WAS SENT TO THE DESIGN ENGINEER AGAIN. WITH THIS CORRECTLY ORIENTATED PICTURE, THEY WERE ABLE TO DETERMINE THAT THE SHUNT WAS SET BETWEEN 0.5 AND 2.5 CAUSING IT TO OPERATE AT THE 2.5 LEVEL. THIS WAS THE LEVEL THE SURGEON WAS HOPING FOR. REPORTEDLY, EVEN WITH THAT INFORMATION, THE SURGEON SEEMED TO BELIEVE THE VALVE WAS SUFFERING FROM REVERSE POLARITY SINCE IN (B)(6), A FOLLOW-UP MAGNETIC RESONANCE IMAGING (MRI) DEMONSTRATED EXTREME VENTRICULAR DECOMPRESSION WITH BILATERAL SUBDURAL FLUID COLLECTI ONS FROM OVERDRAINAGE AND REMOVED THE SHUNT FROM THE PATIENT.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6616875 ↗
• InjuryMay 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT WENT TO THE HOSPITAL ABOUT THREE WEEKS AFTER IMPLANT WITH SEVERE VOMITING AND HEADACHE COMPLAINTS. ACCORDING TO THE REPORT, THE VENTRICULAR DECREASE (BECOMING SMALLER) COULD NOT BE SEEN AT THE TOMOGRAPHY, AND THE PHYSICIAN DECIDED THAT THE VALVE ¿DID NOT WORK.¿ THE CAUSE OF THE DEVICE NOT WORKING WAS NOT DETERMINED AND IT WAS STATED THAT IT WAS NOT OCCLUDED. REPORTEDLY, THE DEVICE WAS REPLACED WITH A NEW ONE AND THERE WAS NO INJURY.

  Patient problems: Headache; Therapeutic Response, Decreased; Vomiting

  MAUDE report 6539090 ↗

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