BioGlide® 91503 (UDI 00763000027834)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00763000027834), received between Apr 27, 2022 and May 20, 2026 — classified as 6 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (17 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT A VENTRICULOPERITONEAL SHUNT PROCEDURE DUE TO POST-TRAUMATIC HYDROCEPHALUS. POSTOPERATIVELY, THE PATIENT DEVELOPED A SEVERE INFECTION AND THE IMPLANTED DEVICES WERE SUBSEQUENTLY REMOVED. AFTER ALL CLINICAL INDICATORS MET THE REQUIRED STANDARDS, A REPEAT VENTRICULOPERITONEAL SHUNT PROCEDURE WAS PERFORMED USING NEW DEVICES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: Unspecified Infection

  MAUDE report 25229915 ↗
• MalfunctionMay 12, 2026Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT DURING CEREBROSPINAL FLUID DRAINAGE USING THE DEVICE, THE DOCTOR OBSERVED FLUID LEAKAGE/RUPTURE AT THE TAIL END. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148052 ↗
• MalfunctionDec 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT UNDERWENT A VENTRI CULOPERITONEAL SHUNT PROCEDURE FOR POST-TRAUMATIC HYDROCEPHALUS. DURING PRE-FILLING OF THE CATHETER WITH NORMAL SALINE, LEAKAGE WAS DETECTED. THE DEVICES WERE SUBSEQUENTLY REPLACED WITH NEW CATHETER AND VALVE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23755993 ↗
• MalfunctionDec 5, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT ON (B)(6) 2025, DURING A VENTRICULOPERITONEAL SHUNT PROCEDURE, THE CHIEF SURGEON DISCOVERED THAT THE DEVICE WAS DAMAGED INTRAOPERATIVELY AND IMMEDIATELY REPLACED IT WITH A NEW DEVICE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23726545 ↗
• MalfunctionNov 13, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT ON (B)(6) 2025, WHEN THE DOCTOR USED REPORTED PRODUCT, THE GUIDEWIRE PUNCTURE LED TO A CATHETER WALL RUPTURE. BECAUSE THE PATIENT HAD PULMONARY TUBERCULOSIS, LEADING TO INFECTING THE PRODUCT , THE HOSPITAL HAD ALREADY TAKEN APPROPRIATE MEASURES. THEREFORE, THE DOCTOR REPLACED IT WITH A NEW ONE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23542352 ↗
• MalfunctionJan 23, 2025Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT DURING THE VENTRICULOPERITONEAL SHUNT SURGERY, THERE WAS A FISSURE IN THE VENTRICULAR END CATHETER, AND LEAKAGE OCCURRED DURING THE OPERATION. THE NEUROSURGERY CUSTOMER REQUESTED THAT THE VENTRICULAR END CATHETER BE REPLACED. THERE WAS A PROCEDURE DELAY OF 30 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21216536 ↗
• MalfunctionDec 30, 2024Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT DURING THE SURGERY, AFTER CONNECTING THE CATHETER TO THE VALVE, IT WAS FOUND THAT THE TAIL END WAS BLOCKED. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW ONE FOR THE SURGERY. THERE WAS A PROCEDURE DELAY OF 30 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21034198 ↗
• InjuryNov 21, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT DURING THE OPERATION, THE FRONT END OF THE CATHETER WAS FOUND TO BE BENT AND TRIED TO CONTINUE TO USE IT. AFTER IMPLANTATION, A CT SCAN FOUND THAT THE FRONT END WAS NOT IN THE IDEAL POSITION. THE PATIENT WAS WORRIED ABOUT CAUSING SERIOUS COMPLICATIONS SO THE PATIENT UNDERWENT SURGERY TO REMOVE IT. THERE WAS A PROCEDURE DELAY OF 20 MINUTES. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20744450 ↗
• MalfunctionNov 6, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THERE WERE CATHETERS WITH BENT FRONT ENDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20625509 ↗
• MalfunctionNov 6, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THERE WERE CATHETERS WITH BENT FRONT ENDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20625393 ↗
• MalfunctionNov 6, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THERE WERE CATHETERS WITH BENT FRONT ENDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20625326 ↗
• MalfunctionNov 6, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THERE WERE CATHETERS WITH BENT FRONT ENDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20624634 ↗
• MalfunctionNov 6, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THERE WERE CATHETERS WITH BENT FRONT ENDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20624317 ↗
• MalfunctionNov 6, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THERE WERE CATHETERS WITH BENT FRONT ENDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20624184 ↗
• MalfunctionNov 6, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THERE WERE CATHETERS WITH BENT FRONT ENDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20624174 ↗
• InjuryOct 28, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THE FRONT END OF THE CATHETER WAS FOUND TO BE BENT DURING THE OPERATION, AND IT WAS CONTINUED TO BE USED. AFTER IMPLANTATION, THE FOLLOWING DAY, A CT SCAN FOUND THAT THE FRONT END WAS NOT IN THE IDEAL POSITION. THERE WAS CONCERN ABOUT IT CAUSING SERIOUS COMPLICATIONS, SO IT WAS REMOVED BY SURGERY. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20543669 ↗
• InjuryOct 14, 2024Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT THE PATIENT'S HYDROCEPHALUS DID NOT IMPROVE SIGNIFICANTLY AFTER THE SHUNT SURGERY. IT WAS LATER DISCOVERED THAT THE SHUNT WAS BLOCKED. A SECOND SURGERY WAS PERFORMED TO REPLACE THE SHUNT. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20438637 ↗
• MalfunctionJan 23, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT WHEN THE DOCTOR WAS PERFORMING THE SHUNT OPERATION, THE DOCTOR OPENED THE INNER PACKAGING AND FOUND THAT THE FRONT END OF THE CATHETER WAS BENT. THE CATHETER WAS REPLACED WITH A NEW ONE TO COMPLETE THE OPERATION. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563460 ↗
• MalfunctionDec 18, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A HYDROCEPHALUS CATHETER. IT WAS REPORTED THAT THE SURGEON WAS PERFORMING SURGERY, AND THE CATHETER BROKE. THE CATHETER WAS REPLACED WITH A NEW ONE TO COMPLETE THE SURGERY. THERE WAS A PROCEDURE DELAY OF 30 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18345049 ↗
• InjuryOct 12, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT AND CATHETER USED DURING A PROCEDURE. IT WAS REPORTED THAT ONE MONTH AFTER THE PATIENT WAS IMPLANTED WITH THE SHUNT SYSTEM, THERE WAS FLUID ACCUMULATION FOUND NEAR THE VALVE. THE DOCTOR THOUGHT THE VALVE AND TUBE WERE DETACHED. HOWEVER, WHEN OPENED IT AGAIN, IT WAS DISCOVERED THAT THE VALVE WAS LEAKING FLUID.THE SHUNT AND CATHETER WERE REPLACED. IT WAS NOTED THE PRODUCT WAS DAMAGED. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17920057 ↗
• MalfunctionOct 11, 2023Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT AFTER THE PATIENT WAS IMPLANTED WITH A HYDROPHILIC-COATED PRE SSURE-ADJUSTABLE SHUNT TUBE, THE SHUNT WAS NOT SMOOTH. THE SHUNT TUBE WAS REPLACED WITH PRODUCTS OF THE SAME MODEL. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17911984 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT 1 YEAR AND 3 MONTHS AFTER THE DEVICE WAS IMPLANTED THE PATIENT WAS INFECTED. THE DEVICE WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17368349 ↗
• MalfunctionApr 27, 2022Break; Fracture; Component Missing; Break; Fracture; Component Missing

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER USED DURING A VENTRICULOPERITONEAL SHUNT SURGERY. IT WAS REPORTED THAT DURING THE PROCESS OF IMPLANTING THE MATERIAL, THE DOCTOR FOUND THAT THERE WAS NO RIGHT-ANGLE CLIP IN THE CEREBROSPINAL FLUID SHUNT AND ACCESSORIES. THEY REPLACED IT WITH A SIMILAR PRODUCT, AND THE SURGERY WENT SMOOTHLY. DELAY INFORMATION WAS UNKNOWN. IT WAS ALSO UNKNOWN IF THE PRODUCT MADE CONTACT WITH THE PATIENT OR PATIENT WITH INFECTION DISEASE. IT WAS REPORTED THAT THE PRODUCT WAS NOT DAMAGED. THERE WAS NO REPORTED IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS NO DELAY. CAUSE WAS UNKNOWN. IT WAS ALSO UNKNOWN IF THE PRODUCT MADE CONTACT WITH THAT PATIENT OR IF THE CLIP WAS BROKEN OFF OF THE SHUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14219879 ↗

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-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 ULT
• 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 - VAL
• 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-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-1125-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782K. Sizes:5.5CM in length, REF (240) 27782K. Each catheter is provided in a sealed Tyvek plas
• 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-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-1134-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782A. Sizes: 4 CM in length, REF (240) 27782 a. Each catheter is provided in a sealed Tyvek pla
• 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-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-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-1149-2009 · Feb 12, 2009 · Terminated
  Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27802F. 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-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-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

…and 16 more.