BioGlideRecalls & reported problems across all models
Medtronic Ps Medical, Inc. · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 80
- Deaths reported
- 0
- Injuries reported
- 40
- Recalls
- 0
We found 10 models of BioGlide by Medtronic Ps Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 80 adverse event reports in the FDA's MAUDE database, received between Dec 7, 2016 and Sep 15, 2026 — classified as 40 injuries, 40 malfunctions.
The most frequently reported specific device problem is “Break” (33 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
Reports received per month, all models
Most reported BioGlide problems
Device problems
- Break33
- Fracture32
- Complete Blockage12
- Fluid/Blood Leak12
- Adverse Event Without Identified Device or Use Problem10
- Infusion or Flow Problem7
- Insufficient Device Problem Information3
- Device Operates Differently Than Expected2
Patient problems
- No Clinical Signs, Symptoms or Conditions42
- No Known Impact Or Consequence To Patient11
- Unspecified Infection6
- Fever5
- Unspecified Tissue Injury5
- Insufficient Information4
- Therapeutic Effects, Unexpected4
- Therapeutic Response, Decreased4
BioGlide models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BioGlide® 91503Shunt, central nervous system and components23 reports
- BioGlide® 93522Shunt, central nervous system and components19 reports
- BioGlide® 91503Shunt, central nervous system and components17 reports
- BioGlide® 93522Shunt, central nervous system and components8 reports
- BioGlide 27705Device, monitoring, intracranial pressure5 reports
- BioGlide® 27536Shunt, central nervous system and components2 reports
- BioGlide® 96118Shunt, central nervous system and components2 reports
- BioGlide® 27705Device, monitoring, intracranial pressure2 reports
- BioGlide® 91503Shunt, central nervous system and components1 report
- BioGlide® 27726Shunt, central nervous system and components1 report
Recent BioGlide adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗MalfunctionJan 29, 2026Break; Fluid/Blood Leak; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT WHEN THE TUBE WAS OPENED FOR A PATENCY TEST, IT WAS FOUND TO BE DAMAGED AND LEAKING. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24209077 ↗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 ↗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 ↗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 ↗InjuryJul 23, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER BEING USED AS A PROXIMAL COMPONENT TO DRAIN AND/OR MONITOR CEREBROSPINAL FLUID (CSF) FROM THE LATERAL VENTRICLE. IT WAS REPORTED THAT ON (B)(6) 2025, THE HYDROPHILIC COATED CATHETER WAS PLACED IN THE PATIENT, AND ON (B)(6) 2025, IT WAS DISCOVERED THAT THE PATIENT'S BED SHEET WAS WET, AND AT THE THREE-WAY CONNECTION OF THE EPIDURAL DRAINAGE TUBE, IT WAS DISCONNECTED CAUSING LIQUID LEAKAGE. THE CATHETER WAS REPLACED WITH ANOTHER ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22574723 ↗MalfunctionJun 13, 2025Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THE SURGEON DISCOVERED A CRACK IN THE TIP OF THE CATHETER DURING THE PLACEMENT PROCESS. THE EXTERNAL DRAINAGE CATHETER WAS PROMPTLY REPLACED TO COMPLETE THE 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 22203630 ↗MalfunctionMay 28, 2025Complete Blockage; Complete Blockage
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM CATHETER. IT WAS REPORTED THAT WHEN THE SURGEON WAS PERFORMING VENTRICULAR DRAINAGE, THEY FOUND THAT THE CATHETER WAS BLOCKED AT THE TIP. THE CATHETER WAS REPLACED WITH A NEW ONE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. IT WAS INDICATED THE PRODUCT HAD CONTACT WITH A PATIENT WITH SYPHILIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22095609 ↗
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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