BioGlide® 93522 (UDI 00763000027605)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00763000027605), received between Jan 18, 2022 and Sep 15, 2026 — classified as 9 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (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, 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Fluid/Blood Leak

  Medtronic received information regarding a catheter. It was reported that when the physician was about to use the shunt tube for a c erebrospinal fluid shunting procedure, a water leak was found during a test of the shunt tube pathway immediately after the package was opened. No patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772532 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Medtronic received information regarding a catheter. It was reported that the ventriculoperitoneal shunt was intended to drain cerebrospinal fluid in a patient with hydrocephalus, relieve the symptoms of hydrocephalus, and reduce intracranial pressure. Its clinical indications included obstructive hydrocephalus, communicating hydrocephalus, and other conditions requiring cerebrospinal fluid diversion. The patient had a clinical indication for ventriculoperitoneal shunt surgery because of hydrocephalus. On (b)(6) 2026, cranioplasty and ventriculoperitoneal shunt surgery were performed under general anesthesia, and the shunt was implanted. A rejection reaction/inflammation could have occurred after implantation. The patient's intracranial inflammatory response was controlled, cerebrospinal fluid inflammatory indicators were monitored dynamically, and the medical device adverse event was reported. Date of improvement was (b)(6) 2026.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation

  MAUDE report 50754140 ↗
• 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 VENTRICU LOPERITONEAL 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 25229924 ↗
• InjuryJan 15, 2026Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THE PATIENT UNDERWENT VENTRICULOPERITONEAL SHUNT SURGERY WITH LAPAROSCOPIC ASSISTANCE. POSTOPERATIVELY, THE PATIENT DEVELOPED A LOW-GRADE FEVER. AFTER ADJUSTING THE SETTING TO 2.5, THE ANTI-INFECTION TREATMENT WAS EFFECTIVE. HOWEVER, WHEN ADJUSTED TO 1.5, THE FEVER COULD NOT BE CONTROLLED. ABDOMINAL CT SHOWED LOCALIZED THICKENING AROUND THE PERITONEAL END OF THE DRAINAGE TUBE. THE DRAINAGE TUBE WAS REMOVED, AND FLUSHING REVEALED DAMAGE TO THE DRAINAGE TUBE. THE FEVER WAS CONSIDERED TO BE CAUSED BY ASEPTIC INFLAMMATION IN THE ABDOMINAL MUSCLES DUE TO CEREBROSPINAL FLUID LEAKAGE FROM THE DAMAGED DRAINAGE TUBE. THE CATHETER WAS REPLACED WAS A NEW ONE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: Fever; Inflammation

  MAUDE report 24079777 ↗
• MalfunctionJan 12, 2026Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THE CUSTOMER OPENED IT FOR A ROUTINE PATENCY CHECK AND DISCOVERED THE CATHETER WAS DAMAGED AND LEAKING. THE CATHETER WAS REPLACED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036302 ↗
• MalfunctionAug 22, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT ON (B)(6) 2025, DURING A VENTRICULOPERITONEAL SHUNT SURGERY, THE DOCTOR DISCOVERED THAT THE PRODUCT WAS DAMAGED/RUPTURED. IT WAS IMMEDIATELY REPLACED 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 22871970 ↗
• MalfunctionApr 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT DURING A VENTRICULOPERITONEAL SHUNT OPERATION, THE DOCTOR DISCOVERED THAT THE TUBE AT THE ABDOMINAL END WAS LEAKING. THE DEVICE WAS REPLACED WITH A SPARE PRODUCT 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 21738269 ↗
• MalfunctionJan 15, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT ON (B)(6) 2025, THE DOCTOR USED THE REPORTED DEVICE DURING SURGERY. A PROBLEM OCCURRED WITH THE DEVICE, AND CRACKS APPEARED IN THE TUBE. THE DEVICE WAS REPLACED 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 21157408 ↗
• InjuryNov 7, 2024Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT AFTER THE SHUNT WAS INSERTED, THE PATIENT EXPERIENCED POOR DRAINAGE, AND THE SYMPTOMS OF HYDROCEPHALUS DID NOT IMPROVE. AFTER INVESTIGATING, IT WAS FOUND THAT THE SHUNT WAS BLOCKED. A SECOND SURGERY WAS PERFORMED TO REPLACE WITH A NEW SHUNT. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20629929 ↗
• 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 20438648 ↗
• MalfunctionFeb 5, 2024Fluid/Blood Leak; Product Quality Problem; Fluid/Blood Leak; Product Quality Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A PERITONEAL CATHETER. IT WAS REPORTED THAT BEFORE IMPLANTATION, IT WAS FOUND THAT THE CATHETER WAS LEAKING LIQUID AT ABOUT 11 CENTIMETERS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640159 ↗
• MalfunctionAug 4, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER USED DURING A PROCEDURE. IT WAS REPORTED THAT WHEN OPENING THE PACKAGE FOR INSPECTION, IT WAS FOUND THAT THE ABDOMINAL PORT WAS DAMAGED, AND THE SURGEON THOUGHT IT WAS A PRODUCT QUALITY PROBLEM. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17459668 ↗
• MalfunctionAug 1, 2023Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THE HEALTHCARE PROFESSIONAL WAS PERFORMING A VENTRICULOPERITONEAL SHUNT SURGERY. THE ABDOMINAL CATHETER WAS FOUND TO BE BLOCKED. AFTER REPLACING WITH OTHER PRODUCT OF THE SAME MODEL, THE OPERATION WENT SMOOTHLY. THERE WAS NO REPORTED IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17434543 ↗
• MalfunctionJul 19, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT THE PATIENT SUFFERED FROM POST-TRAUMATIC HYDROCEPHALUS. THE PATIENT NEEDED VENTRICULOPERITONEAL SHUNTING. IT WAS FOUND DURING OPERATION THAT THE TUBE WALL LEAKED LIQUID. THE DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17351705 ↗
• InjuryJun 14, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT DURING THE SHUNT OPERATION, WHEN THE CATHETER AT THE ABDOMINAL END WAS INSERTED INTO THE BODY, IT WAS FOUND THAT THE CATHETER WAS BROKEN, SO THAT THE CATHETER WAS TAKEN OUT AND REPLACED WITH A NEW ONE. THERE WAS A 30 MINUTE DELAY. THERE WERE NO REPORTED KNOWN CONTRIBUTING FACTORS THAT COULD HAVE LEAD TO THIS EVENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17126461 ↗
• InjuryApr 5, 2023Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT IN THE POST-OPERATIVE EXAMINATION FOUND THAT THE END OF THE SHUNT WAS WRAPPED BY TISSUE, CAUSING THE SHUNT TO BE BLOCKED. THE DEVICE WAS EXPLANTED, AND REPLACED WITH ANOTHER DEVICE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16682611 ↗
• InjuryApr 5, 2023Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT BEING USED DURING A SHUNT SURGERY. AFTER THE POSTOPERATIVE REVIEW, IT WAS FOUND THAT THE END OF THE ABDOMINAL CAVITY WAS WRAPPED BY A MEMBRANE, WHICH CAUSED THE SHUNT TO BE BLOCKED. THE DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED. THE REPRESENTATIVE STATED THE FOLLOWING. "USUALLY WHEN A DOCTOR ENCOUNTERS A CATHETER BLOCKAGE PROBLEM, HE WILL FIRST CONSIDER THE END BLOCKAGE CAUSED BY THE PATIENT'S CONSTITUTION OR THE PLACEMENT OF THE CATHETER AT THE ABDOMINAL END, SO HE WILL NOT CONSIDER THE PROBLEM OF THE CATHETER PRODUCT ITSELF AT THE FIRST TIME."

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16682258 ↗
• MalfunctionSep 12, 2022Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT DURING THE VENTRICULOPERITONEAL SHUNT SURGERY IN THE OPERATING ROOM THE HEALTH CARE PROFESSIONAL FOUND THAT THE CATHETER WAS BLOCKED DURING THE IMPLANTATION OF MATERIALS. THE REPLACED IT WITH ANOTHER CATHETER. AFTER REPLACEMENT THE SURGERY WENT SMOOTHLY. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THE TYPE OF VALVE BEING USED DURING THE CASE WAS AN ORDINARY ADJUSTABLE PRESSURE VALVE. ACCORDING TO THE HEALTH CARE PROFESSIONAL'S DESCRIPTION, DURING THE CATHETER IMPLANTATION PROCESS, WHEN THE SHUNT SYSTEM WAS CONNECTED, IT WAS FOUND THAT THE CATHETER WAS BLOCKED AND COULD NOT BE DRAINED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15403036 ↗
• InjuryJan 18, 2022Fracture; Fracture

  IT WAS REPORTED THAT A WEEK AFTER THE VENTRICULOPERITIONEAL SURGERY, THE PATIENT WAS IN POOR CONDITION AND FELT UNWELL. WHEN THEY WENT TO THE HOSPITAL FOR RE-EXAMINATION, IT WAS FOUND THAT THE CATHETER WAS DAMAGED/BROKEN AFTER A SERIES OF EXAMINATIONS. A SECOND SURGERY WAS PERFORMED. THE PATIENT HAD BEEN DISCHARGED AND AT HOME; HOWEVER, THE PATIENT'S LIVING SITUATION WAS THAT THEY COULDN'T TAKE CARE OF THEMSELVES.

  Patient problems: Malaise

  MAUDE report 13285964 ↗