Strata, BioGlideRecalls & reported problems across all models
Medtronic Ps Medical, Inc. · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls
- 0
We found 8 models of Strata, BioGlide by Medtronic Ps Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2016 and Dec 16, 2018 — classified as 14 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (8 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Strata, BioGlide problems
Device problems
- Device Operates Differently Than Expected8
- Appropriate Device Problem Term/Code Not Available5
- Inaccurate Flow Rate4
- Leak/Splash4
- Occlusion Within Device2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Fluid/Blood Leak1
Patient problems
- No Known Impact Or Consequence To Patient12
- Therapeutic Response, Decreased10
- Therapeutic Effects, Unexpected2
- Cognitive Changes1
- Complaint, Ill-Defined1
- Headache1
- Irritability1
- Neurological Deficit/Dysfunction1
Strata, BioGlide models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Strata®, BioGlide® 27819Shunt, central nervous system and components11 reports
- Strata®, BioGlide® 92856Shunt, central nervous system and components4 reports
- Strata®, BioGlide® 92866Shunt, central nervous system and components3 reports
- Strata®, BioGlide® 27818Shunt, central nervous system and components3 reports
- Strata®, BioGlide® 96665Shunt, central nervous system and components2 reports
- Strata®, BioGlide® 27822Shunt, central nervous system and components1 report
- Strata®, BioGlide® 92355Shunt, central nervous system and components1 report
- Strata®, BioGlide® 92365Shunt, central nervous system and components1 report
Recent Strata, BioGlide adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING THE PATENCY CHECK, THE PHYSICIAN FOUND THAT THE DELTA CHAMBER LEAKED. THE VALVE WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8167905 ↗InjuryOct 22, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO FACTORS KNOWN CONTRIBUTING TO THE FAILURE. IT WAS STATED THAT THE PATIENT WAS DOING WELL.
Patient problems: Cognitive Changes; Complaint, Ill-Defined; Irritability; Neurological Deficit/Dysfunction; Pain
MAUDE report 7993063 ↗MalfunctionAug 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT REGARDLESS OF THE SETTING THE PATIENT'S SHUNT WAS SET TO, THERE APPEARED TO BE NO DIFFERENCE. IT WAS NOTED THEY WERE STILL WORKING WITH A NEUROSURGEON TO SEE WHAT STEPS THEY NEEDED TO TAKE NEXT.
Patient problems: Therapeutic Effects, Unexpected
MAUDE report 7822910 ↗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 ↗MalfunctionApr 25, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING IMPLANT, THE CEREBROSPINAL FLUID DID NOT FLOW THROUGH THE VALVE. THE VALVE WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7458234 ↗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 ↗MalfunctionFeb 6, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT PRIOR TO IMPLANT, THE FLUSHING OF THE SHUNT FAILED WHEN PUMPING THE RESERVOIR. IT WAS STATED THE SHUNT WAS CONSIDERED TO HAVE AN ANOMALY AND WAS REPLACED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7245625 ↗InjuryDec 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT¿S ABDOMEN WAS COVERED WITH FLUID AND THERE WAS A SUSPECTED INFECTION ABOUT 3 MONTHS AFTER IMPLANT. THE DEVICE WAS EXPLANTED. A CULTURE INDICATED THERE WERE INFLAMMATORY CHANGES AND AN EPIDERMIS INFECTION. THE PATIENT¿S STATUS WAS NOTED AS ALIVE-NO INJURY.
Patient problems: Unspecified Infection
MAUDE report 7144189 ↗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 ↗MalfunctionNov 29, 2017Inaccurate Flow Rate; Inaccurate Flow Rate
IT WAS THAT DURING THE PROCEDURE, FLUID SUCH AS CEREBROSPINAL FLUID (CSF) DID NOT DRAIN SMOOTHLY WHEN PUMPING WAS PERFORMED USING CSF AND SALINE. THEREFORE, THE USE OF THE DEVICES WERE DISCONTINUED. PER THE PHYSICIAN, THE FLOW BACK FROM THE RESERVOIR WAS SLOW AND DISCHARGE OF THE CSF COULD NOT BE OBSERVED. AS FURTHER DIFFICULTIES WERE EXPECTED IN CHECKING THE DEVICE OPERATION ONCE THEY WERE PLACED SUBCUTANEOUSLY, THE USE OF THE DEVICES WERE DISCONTINUED. AFTER IMPLANTING A PART OF THE LUMBAR CATHETER IN THE PATIENT, A BACKUP LUMBAR PERITIONEAL (LP) SHUNT WAS UNPACKED AND CONNECTED WITH THE LUMBAR CATHETER AND LP VALVE, AND FURTHER CONNECTED WITH THE LP SHUNT. IT WAS NOTED THAT THE PROXIMAL EDGE OF THE LUMBAR CATHETER HAD REMAINED INSIDE THE PATIENT'S BODY. THE DISTAL EDGE WAS EXPLANTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7068834 ↗MalfunctionNov 27, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING SURGERY, THE BOTTOM OF THE RESERVOIR LEAKED WHEN THE PHYSICIAN SQUEEZED THE RESERVOIR. THE PRODUCT WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7060939 ↗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 ↗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 ↗InjurySep 24, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE POOR EFFECT WAS POOR VALVE DIVERSION.
Patient problems: Therapeutic Response, Decreased
MAUDE report 6889299 ↗
Other Medtronic Ps Medical, Inc. products
All Medtronic Ps Medical, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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