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BioGlide® 91503 (UDI 00613994800718)Recalls & reported problems

Medtronic Ps Medical, Inc. · CATH 91503 BIOGLIDE VENT 23CM CLOSED IMP · Class 2 · Implant

All models of BioGlide (10)

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

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994800718), received between Jun 23, 2017 and Jun 23, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

31 other recalls cover devices cleared under the same FDA submission (K951258); 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

  • Device Operates Differently Than Expected1

Patient problems

  • Therapeutic Response, Decreased1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 23, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT AFTER SEVERAL REGULATORY PRESSURES, THE SHUNT EFFECT WAS STILL NOT OBVIOUS, AND THE PATIENT'S CONDITION DID NOT DECREASE. ACCORDING TO THE REPORT, THE PATIENT WAS RELIEVED WHEN THE VALVE WAS REPLACED, AND THE DOCTOR SUSPECTED A VALVE FAILURE.

    Patient problems: Therapeutic Response, Decreased

    MAUDE report 6664092 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951258. One submission often covers many models, so check the product and lot details in each record.

  • Z-1115-2021 · Jan 11, 2021 · Open, Classified
    Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24048 DELTA RGL PL 0.5, 24053 - CHAMBER 24053 DELTA, 24147 -
  • Z-1117-2021 · Jan 11, 2021 · Open, Classified
    Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW 22011 LL - SHUNT 22011 LL INTL ONLY
  • Z-1140-2009 · Feb 12, 2009 · Terminated
    Snap Shunt Ventricular Catheter, Standard, with BioGlide, 3 CM, Ref 27708F. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The
  • Z-1142-2009 · Feb 12, 2009 · Terminated
    Snap Shunt Ventricular Catheter, Standard, with BioGlide, 10 CM, Ref 27708H. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The
  • Z-1132-2009 · Feb 12, 2009 · Terminated
    Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782C. Sizes: 6 CM in length, REF (240) 27782C. Each catheter is provided in a sealed Tyvek plas
  • Z-1152-2009 · Feb 12, 2009 · Terminated
    Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 11 CM, Ref 27802J. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar p
  • Z-1141-2009 · Feb 12, 2009 · Terminated
    Snap Shunt Ventricular Catheter, Standard, with BioGlide, 9CM, Ref 27708G. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The s
  • Z-1150-2009 · Feb 12, 2009 · Terminated
    Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 9 CM, Ref 27802G. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar po
  • Z-1136-2009 · Feb 12, 2009 · Terminated
    Snap Shunt Ventricular Catheter, Standard, with BioGlide, 5 CM, Ref 27708B. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The
  • Z-1138-2009 · Feb 12, 2009 · Terminated
    Snap Shunt Ventricular Catheter, Standard, with BioGlide, 7 CM, Ref 27708D. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The
  • Z-1128-2009 · Feb 12, 2009 · Terminated
    Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782G. Sizes 10cm in length, REF (240) 27782G. Each catheter is provided in a sealed Tyvek plast
  • Z-1146-2009 · Feb 12, 2009 · Terminated
    Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 5 CM, Ref 27802C. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar po
  • Z-1144-2009 · Feb 12, 2009 · Terminated
    Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 3 CM, Ref 27802A. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar po
  • Z-1137-2009 · Feb 12, 2009 · Terminated
    Snap Shunt Ventricular Catheter, Standard, with BioGlide, 6 CM, Ref 27708C. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The
  • Z-1148-2009 · Feb 12, 2009 · Terminated
    Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 7 CM, Ref 27802E. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar po

…and 16 more.

Other Shunt, central nervous system and components devices

All Shunt, central nervous system and components devices →

Sources and updates

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