BioGlide® 27536Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169472808), received between Mar 14, 2018 and Feb 1, 2019 — classified as 2 injuries.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 1, 2019Fracture; Fracture

  IT WAS REPORTED THE CATHETER WAS IMPLANTED IN 2016 AND IT FRACTURED IN THE ABDOMINAL CAVITY. IT WAS STATED THE BROKEN PIECES WERE RETRIEVED. THE FRAGMENTS WERE REMOVED BY USING AN ENDOSCOPE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT A REPLACEMENT PROCEDURE WAS PERFORMED BECAUSE THERE WAS A CLOG IN THE SHUNT SYSTEM WHICH WAS IMPLANTED IN 2016. A CT SCAN AFTER THE REPLACEMENT PROCEDURE CONFIRMED BROKEN PIECE(S) OF THE CATHETER WITHIN THE PERITONEAL CAVITY. THE BROKEN PIECE(S) WAS PART OF THE CATHETER WHICH WAS IMPLANTED IN 2016. IT WAS NOTED THAT THE PATIENT WAS A CHILD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8299373 ↗
• 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 7338965 ↗

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-1143-2009 · Feb 12, 2009 · Terminated
  Snap Shunt Ventricular Catheter, Standard, with BioGlide, 11 CM, Ref 27708J Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The
• Z-1133-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782B. Sizes: 5 CM in length, REF (240) 27782B. Each catheter is provided in a sealed Tyvek plas
• 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-1124-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782L. Sizes: 3 CM in length, REF (240) 27782L. Each catheter is provided in a sealed Tyvek plas
• 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-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-1151-2009 · Feb 12, 2009 · Terminated
  Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 10 CM, Ref 27802H. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar p
• Z-1131-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782D. Sizes: 7 CM in length, REF (240) 27782D. Each catheter is provided in a sealed Tyvek plas
• 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
• Z-1126-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782J. Sizes: 4.5 CM in length, REF (240) 27782J. Each catheter is provided in a sealed Tyvek pl
• 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-1145-2009 · Feb 12, 2009 · Terminated
  Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 4 CM, Ref 27802B. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar po
• 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

…and 16 more.