BioGlide® 91503 (UDI 00643169466289)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00643169466289), received between Mar 24, 2017 and Apr 29, 2022 — classified as 13 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2022Break; Fracture; Infusion or Flow Problem; Break; Fracture; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH THE SHUNT, BUT LATELY WAS OBSERVED THAT THERE WAS NO PROPER CSF DRAINAGE. THE HEALTH CARE PROFESSIONAL EXAMINED AND OBSERVED THAT THE SHUNT WAS BROKEN AND MALFUNCTIONED. THE PROCEDURE WAS COMPLETED AND NOW NEEDS REVISION AS THE PRODUCT IS NOT FUNCTIONAL. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE HEALTH CARE PROFESSIONAL DID NOT KNOW THE SHUNT WAS NOT FUNCTIONING CORRECTLY WHEN IT WAS IMPLANTED INTO THE PATIENT. THE PATIENT WAS IMPLANTED WITH THE DEVICE FOR 2 YEARS AND 4 MONTHS BEFORE IT STARTED TO MALFUNCTION. THE PATIENT EXPERIENCED THE FOLLOWING SYMPTOMS: HEADACHE, SEIZURES , CSF WAS GETTING COLLECTED IN THE BRAIN PARENCHYMA. AFTER THE PROCEDURE THE PATIENT WAS DOING WELL UNTIL THIS (B)(6) WHICH WAS HIS LAST FOLLOW UP. THE REVISION SURGERY WAS ON (B)(6) 2022.

  Patient problems: Cerebrospinal Fluid Leakage; Convulsion/Seizure; Headache

  MAUDE report 14253166 ↗
• MalfunctionMay 27, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE VENTRICLE-ABDOMINAL SHUNT SURGERY WAS PERFORMED ON (B)(6) 2021, AND THE INTRACRANIAL PRESSURE OF THE PATIENT WAS SIGNIFICANTLY REDUCED AFTER THE SURGERY. AFTER THE PRESSURE WAS ADJUSTED ON (B)(6) 2021, THE INTRACRANIAL PRESSURE OF THE PATIENT GRADUALLY INCREASED. AFTER REPEATED ADJUSTMENTS, THE EFFECT WAS NOT SATISFACTORY.

  Patient problems: Insufficient Information

  MAUDE report 11894318 ↗
• InjuryDec 29, 2020Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE SHUNT WAS EXPLANTED DUE TO BEING BLOCKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11088073 ↗
• InjuryOct 20, 2020Infusion or Flow Problem; Infusion or Flow Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10708361 ↗
• InjuryJul 1, 2020Infusion or Flow Problem; Infusion or Flow Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 10217757 ↗
• InjuryMar 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A SHUNT SYSTEM, BUT THE SHUNT EFFECT WAS POOR. IT WAS STATED THAT THE PATIENT'S CEREBROSPINAL FLUID SITUATION DID NOT IMPROVE AFTER THE SHUNT WAS IMPLANTED. THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE SHUNT SYSTEM WAS REPLACED WITH A NEW ONE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE - NO INJURY.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 9898190 ↗
• InjuryMar 6, 2020Disconnection; Disconnection

  IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH AN ADJUSTABLE PRESSURE SHUNT ON (B)(6) 2019 DUE TO HYDROCEPHALUS. IN (B)(6) 2020, THE PATIENT'S FAMILY FOUND THE PRESSURE REGULATOR VALVE IMPLANTED WAS ORIGINALLY ABOVE THE COCHLEA, BUT NOW, THE POSITION OF THE PRESSURE REGULATOR VALVE SLIPPED BELOW THE COCHLEA. THE FAMILY CONTACTED THE SURGEON TO INFORM THE DOCTOR OF THE SITUATION OF THE VALVE DISPLACEMENT, AND THE SURGEON STATED THAT THEY COULD NOT JUDGE THE SITUATION OF THE PATIENT BY THE PHONE. IT WAS RECOMMENDED THAT THE PATIENT UNDERGO A LOCAL CT EXAMINATION AND CONFIRM FOLLOW-UP TREATMENT PLAN BASED ON THE RESULTS OF THE EXAMINATION. THE PATIENT WAS AT HOME WITHOUT ANY DISCOMFORT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS TOO YOUNG AND RELATIVELY LIVE AND ACTIVE RESULTING IN THE LOOSENING OF THE INTERFACE BETWEEN THE VALVE AND THE VENTRICULAR END. THE DOCTOR RECONNECTED THE VALVE THROUGH SURGERY AND INFORMED THEM ABOUT POSTOPERATIVE PRECAUTIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9802167 ↗
• InjuryMar 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH A VENTRICULOPERITONEAL SHUNT. THE PATIENT DEVELOPED A FEVER 3 DAYS AFTER THE SURGERY AND WAS TREATED CONSERVATIVELY WITH ANTIBIOTICS BUT FAILED TO ACHIEVE THE EXPECTED EFFECT. IT WAS THOUGHT THAT THERE MIGHT BE A SHUNT INFECTION. THE SHUNT WAS EXPLANTED, AND THE CORRESPONDING TREATMENT MEASURES WOULD BE TAKEN ACCORDING TO THE SPECIFIC SITUATION OF THE PATIENT. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE - WITH INJURY.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 9800042 ↗
• InjuryDec 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE VENTRICULAR CATHETER WAS PART OF A REVISION SURGERY. THE DIRECTOR HAD ADVISED THAT THE VENTRICULAR CATHETER SHOULD NOT BE PULLED OUT OF THE VENTRICLE TO AVOID A POSSIBLE CEREBRAL HEMORRHAGE. THE VENTRICULAR CATHETER WAS CUT OFF, AND THE INTERFACE WAS LIGATED DIRECTLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9439107 ↗
• InjuryApr 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED REGARDING A PATIENT UNDERGOING CEREBRAL PERITONEAL SHUNT SURGERY DUE TO TRAUMATIC BRAIN INJURY. IT WAS REPORTED THAT THE PATIENT HAD A CONTINUOUS FEVER THAT OCCURRED ONE WEEK AFTER SURGERY AND DID NOT IMPROVE. AS THERE WAS A RISK OF INFECTION, THE DEVICE WAS REMOVED. AFTER THE PATIENT RETURNED TO NORMAL ANOTHER SURGERY WAS COMPLETED. THERE WAS NO PRODUCT DAMAGE. THERE WERE NO RELATED PATIENT SYMPTOMS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO ADJUSTMENT WAS DONE ANYTIME AFTER IMPLANTATION. NO ACTIVITIES/ANALYSES WERE DONE ON THE VALVE AFTER THE REMOVAL FROM THE PATIENT PRIOR TO SENDING IT TO THE MANUFACTURER. THE VALVE WAS NOT BATHED IN ANY CHEMICALS OR ANTIBIOTICS PRIOR TO IMPLANTATION. NO MRI'S WERE PERFORMED WHILE THE DEVICE WAS IMPLANTED.

  Patient problems: Fever

  MAUDE report 8562408 ↗
• InjuryDec 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT¿S ABDOMEN WAS COVERED WITH FLUID AND THERE WAS A SUSPECTED INFECTION ABOUT 3 MONTHS AFTER IMPLANT. THE DEVICE WAS EXPLANTED. A CULTURE INDICATED THERE WERE INFLAMMATORY CHANGES AND AN EPIDERMIS INFECTION. THE PATIENT¿S STATUS WAS NOTED AS ALIVE-NO INJURY.

  Patient problems: Unspecified Infection

  MAUDE report 7144192 ↗
• InjurySep 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DEVICE WAS REMOVED AS PART OF A SHUNT REPLACEMENT.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6889300 ↗
• MalfunctionJun 28, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT DURING THE PROCEDURE, IT WAS CONFIRMED THAT THE SHUNT SYSTEM MALFUNCTIONED, AND THE USE OF IT WAS STOPPED. ACCORDING TO THE REPORT, ALTHOUGH THE RESERVOIR OF THE VALVE WAS PUMPED, THERE WAS NO CEREBROSPINAL FLUID. IT WAS STATED THAT THE EVENT OCCURRED WHEN THE BOTH THE PRODUCTS WERE CONNECTED, AND IT WAS UNKNOWN AT PRESENT WHICH DEVICE WAS NOT WORKING. REPORTEDLY, THERE WAS NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6674192 ↗
• InjuryJun 15, 2017Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DISEASE EXPECTED TO BE TREATED WAS CRANIOCEREBRAL TRAUMA. ACCORDING TO THE REPORT, ON (B)(6) 2017, THE PATIENT HAD RIGHT BRAIN SKULL REPAIR AND LEFT BRAIN SHUNT PLACEMENT. BEFORE THE SURGERY, THE PATIENT'S LUMBAR PUNCTURE PRESSURE WAS 300, AND THE IMPLANTED VALVE PRESSURE WAS SET AT 2.5. AFTER 2 DAYS, THE VENTRICLE DIDN'T DECREASE, AND THE PHYSICIAN ADJUSTED THE PRESSURE TO 2.0 ON (B)(6) 2017. IT WAS STATED THE VENTRICLE STILL DIDN'T REDUCE. ON (B)(6) 2017, THE PHYSICIAN ADJUSTED THE PRESSURE TO 1.5, BUT THE FILM SHOWED NO REDUCTION IN CEREBROSPINAL FLUID. ON (B)(6) 2017, THE PHYSICIAN ADJUSTED THE PRESSURE TO 1.0 BUT WAS STILL INEFFECTIVE. ON (B)(6) THE PHYSICIAN FINALLY ADJUSTED THE PRESSURE TO 0.5. REPORTEDLY, DURING THIS PERIOD, THE PRESSURE WAS NORMAL. THE PATIENT'S FAMILY REPEATEDLY PRESSED THE VALVE POSITION, AND THE ELASTICITY OF THE VALVE WAS GOOD. THE PHYSICIAN PRESSED THE VALVE POSITION, AND THE ELASTICITY WAS GOOD AND BOTH ENDS OF THE CATHETER WERE NOT BLOCKED, BUT THERE WAS NOT NORMAL DRAINAGE. THE PATIENT WASN'T IMPROVING, AND THE DOCTOR MEASURED THE LUMBAR PUNCTURE PRESSURE TO BE AT 400 ON (B)(6) 2017. IT WAS STATED

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6645063 ↗
• InjuryApr 28, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT RECEIVED THE SURGERY ON (B)(6) 2016 DUE TO HYDROCEPHALUS, AND AFTER THE SURGERY, THE HYDROCEPHALUS WAS NOT IMPROVED. ACCORDING TO THE REPORT, 6 MONTHS AFTER THE SURGERY, THE DOCTOR HAD TO EXPLANT THE DEVICE AND RE-IMPLANT WITH A NEW ONE. REPORTEDLY, THE HYDROCEPHALUS WAS IMPROVED, AND THE PATIENT'S CURRENT STATUS WAS WELL.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6531971 ↗
• MalfunctionApr 20, 2017Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THERE WAS DAMAGE ON THE DEVICE FROM THE BEGINNING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6509944 ↗
• MalfunctionMar 24, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE WAS IMPLANTED DUE TO AN ANEURYSM. ACCORDING TO THE REPORT, PRIOR TO THE SURGERY, THE DEVICE WAS FOUND TO BE LEAKING DURING TESTING. REPORTEDLY, THE PHYSICIAN REPLACED THE DEVICE TO SUCCESSFULLY COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6434295 ↗

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-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-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-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-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-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-1129-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782F. Sizes: 9 CM in length, REF (240) 27782F. Each catheter is provided in a sealed Tyvek plas
• 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-1135-2009 · Feb 12, 2009 · Terminated
  Snap Shunt Ventricular Catheter, Standard, with BioGlide, 4 CM, Ref 27708A. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The
• Z-1127-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782H. Sizes: 11 CM in length, REF (240) 27782H. Each catheter is provided in a sealed Tyvek pla
• Z-1130-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782E. Sizes: 8 CM in length, REF (240) 27782E. Each catheter is provided in a sealed Tyvek plas
• 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-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-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.