N/A 9040 ERecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00763000027872), received between Mar 7, 2021 and Jun 18, 2026 — classified as 2 deaths, 7 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (12 reports).

1 other recall cover devices cleared under the same FDA submission (K831678); 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• DeathJun 18, 2026Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NON-ADJUSTABLE SHUNT/VALVE. IT WAS REPORTED THAT POST-OPERATIVELY, THE PATIENT WAS NOTED TO HAVE DECREASED CONSCIOUSNESS WITH AN IMPRESSION OF INADEQUATE SHUNT/PUMP FUNCTION. FOLLOWING A HEAD CT SCAN EVALUATION, VENTRICULAR ENLARGEMENT WAS OBSERVED. THE VENTRICULAR CATHETER WAS NOTED TO BE IN A GOOD POSITION. THE PATIENT WAS RE-IMPLANTED USING A COMPETITOR SHUNT, HOWEVER, THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS DECEASED. THE PATIENT'S MEDICAL HISTORY WAS SPONTANEOUS COMMUNICATING HYDROCEPHALUS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO TESTING PERFORMED ON EACH COMPONENT TO DETERMINE IF THE SHUNT WAS OCCLUDED. THE TIMELINE BETWEEN SHUNT IMPLANTATION AND ONSET OF DECREASED CONSCIOUSNESS/DEATH WAS 4 DAYS. THE PATIENT'S NEUROLOGICAL ASSESSMENTS BEFORE THE INITIAL PROCEDURE WAS GCS SCORE OF E2M4VETT. NO AUTOPSY WAS PERFORMED. THE SHUNT WAS TESTED INTRA-OPERATIVELY FOR PATENCY.

  Patient problems: Loss of consciousness

  MAUDE report 25553968 ↗
• DeathJun 18, 2026Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NON-ADJUSTABLE SHUNT/VALVE. IT WAS REPORTED THAT POST-OPERATIVELY, THE PATIENT WAS NOTED TO HAVE DECREASED CONSCIOUSNESS WITH AN IMPRESSION OF INADEQUATE SHUNT/PUMP FUNCTION. FOLLOWING A HEAD CT SCAN EVALUATION, VENTRICULAR ENLARGEMENT WAS OBSERVED. THE VENTRICULAR CATHETER WAS NOTED TO BE IN A GOOD POSITION. IT WAS UNKNOWN IF AN INTERVENTION WAS PERFORMED, HOWEVER, A PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS DECEASED. THE PATIENT'S MEDICAL HISTORY WAS OBSTRUCTIVE HYDROCEPHALUS AND SPACE-OCCUPYING LESION (SOL) OF THE INTRACRANIAL CEREBELLUM. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO TESTING PERFORMED ON EACH COMPONENT TO DETERMINE IF THE SHUNT WAS OCCLUDED. THE TIMELINE BETWEEN SHUNT IMPLANTATION AND ONSET OF DECREASED CONSCIOUSNESS/DEATH WAS 29 DAYS. THE PATIENT'S NEUROLOGICAL ASSESSMENTS BEFORE THE INITIAL PROCEDURE WAS GCS SCORE OF E4M6V5. NO AUTOPSY WAS PERFORMED. THE SHUNT WAS TESTED INTRA-OPERATIVELY FOR PATENCY.

  Patient problems: Loss of consciousness

  MAUDE report 25553896 ↗
• InjuryMay 21, 2026Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NON-ADJUSTABLE SHUNT/VALVE. IT WAS REPORTED THAT POST-OPERATIVELY, THE PATIENT WAS NOTED TO HAVE DECREASED CONSCIOUSNESS WITH AN IMPRESSION OF INADEQUATE SHUNT/PUMP FUNCTION. FOLLOWING A HEAD CT SCAN EVALUATION, VENTRICULAR ENLARGEMENT WAS OBSERVED. THE VENTRICULAR CATHETER WAS NOTED TO BE IN A GOOD POSITION. THE DEVICE WAS REPLACED WITH A COMPETITOR'S SHUNT THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. THE PATIENT'S MEDICAL HISTORY WAS SPONTANEOUS SUBARACHNOID HEMORRHAGE (SAH) RUPTURED ANEURYSM M1-M2 BIFURCATION.

  Patient problems: Loss of consciousness

  MAUDE report 25243501 ↗
• InjuryMay 21, 2026Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NON-ADJUSTABLE SHUNT/VALVE. IT WAS REPORTED THAT POST-OPERATIVELY, THE PATIENT WAS NOTED TO HAVE DECREASED CONSCIOUSNESS WITH AN IMPRESSION OF INADEQUATE SHUNT/PUMP FUNCTION. FOLLOWING A HEAD CT SCAN EVALUATION, VENTRICULAR ENLARGEMENT WAS OBSERVED. THE VENTRICULAR CATHETER WAS NOTED TO BE IN A GOOD POSITION. THE DEVICE WAS REPLACED WITH A COMPETITOR'S PRODUCT. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. THE PATIENT'S MEDICAL HISTORY WAS SPONTANEOUS OBSTRUCTIVE HYDROCEPHALUS.

  Patient problems: Loss of consciousness

  MAUDE report 25243393 ↗
• InjuryMay 21, 2026Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NON-ADJUSTABLE SHUNT/VALVE. IT WAS REPORTED THAT POST-OPERATIVELY, THE PATIENT WAS NOTED TO HAVE DECREASED CONSCIOUSNESS WITH AN IMPRESSION OF INADEQUATE SHUNT/PUMP FUNCTION. FOLLOWING A HEAD CT SCAN EVALUATION, VENTRICULAR ENLARGEMENT WAS OBSERVED. THE VENTRICULAR CATHETER WAS NOTED TO BE IN A GOOD POSITION. THE DEVICE WAS REPLACED WITH A COMPETITOR'S SHUNT. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. THE PATIENT'S MEDICAL HISTORY WAS SUBDURAL HEMATOMA (SDH) OSSIFICATION OF THE LIGAMENTUM FLAVUM (OLF) LEFT (L) FRONTOTEMPOROPARIETAL (FTP).

  Patient problems: Loss of consciousness

  MAUDE report 25243059 ↗
• MalfunctionMay 13, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE USED FOR A HYDROCEPHALUS PROCEDURE. IT WAS REPORTED THAT THE THERE WAS VALVE LEAKAG E. 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 25159777 ↗
• MalfunctionMar 17, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT WHEN TESTED, THE CATHETER WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE PROCEDURE WAS FOR HYDROCEPHALUS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617665 ↗
• MalfunctionMar 11, 2026Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT WHEN TESTED, THE VALVE WAS NOT WORKING AS IT COULD NOT DELIVER LIQUID. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. THE PROCEDURE WAS FOR HYDROCEPHALUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567270 ↗
• MalfunctionMar 10, 2026Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT THE PERITONEAL CATHETER BROKE DURING PRE-OP. 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 24556861 ↗
• MalfunctionDec 1, 2025Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT WHEN TESTED BEFORE IMPLANT, THE SURGEON FOUND THAT THE VALVE COULD NOT PASS LIQUID TO THE CATHETER. 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 23679370 ↗
• MalfunctionNov 10, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT THE CATHETER OF THE VENTRICULOPERITONEAL SHUNT BROKE DURING THE PROCEDURE. THE DOCTOR TRIED TO USE A BACK UP PRODUCT OF THE SAME DEVICE, BUT THE CATHETER WAS ALSO BROKE. ANOTHER BACK UP PRODUCT OF THE SAME DEVICE WAS USED, AND IT WAS SUCCESSFULLY IMPLANTED IN THE PATIENT. THE PATIENT'S MEDICAL HISTORY WAS POST EXTERNAL VENTRICULAR DRAINAGE A/I HYDROCEPHALUS OBSTRUCTION E.C. SUBARACHNOID HEMORRHAGE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510421 ↗
• MalfunctionNov 10, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT THE CATHETER OF THE VENTRICULOPERITONEAL SHUNT BROKE DURING THE PROCEDURE. THE DOCTOR TRIED TO USE A BACK UP PRODUCT OF THE SAME DEVICE, BUT THE CATHETER WAS ALSO BROKE. ANOTHER BACK UP PRODUCT OF THE SAME DEVICE WAS USED, AND IT WAS SUCCESSFULLY IMPLANTED IN THE PATIENT. THE PATIENT'S MEDICAL HISTORY WAS POST EXTERNAL VENTRICULAR DRAINAGE A/I HYDROCEPHALUS OBSTRUCTION E.C. SUBARACHNOID HEMORRHAGE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510409 ↗
• MalfunctionOct 22, 2025Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT THE SHUNT WAS BLOCKED. THE SHUNT WAS REPLACED TO COMPLETE THE PROCEDURE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357620 ↗
• InjuryOct 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE/SHUNT. IT WAS REPORTED THAT THE HEALTHCARE PROFESSIONAL OBSERVED SHUNT DYSFUNCTION/NOT PERFORMING PROPERLY. THE PATIENT HAD A REVISION SURGERY AFTER THE SHUNT DYSFUNCTION.

  Patient problems: Decreased Respiratory Rate; Fatigue; Loss of consciousness; Nausea; No Clinical Signs, Symptoms or Conditions; Vomiting

  MAUDE report 23336309 ↗
• InjuryOct 20, 2025Complete Blockage; Complete Blockage

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT AFTER IMPLANTATION OF THE SHUNT, THE PATIENT EXPERIENCED LIFE-THREATENING SYMPTOMS SUCH AS ACUTE HYDROCEPHALUS, LOSS OF CONSCIOUSNESS, SEVERE NAUSEA AND VOMITING, DROWSINESS, AND RESPIRATORY DEPRESSION.

  Patient problems: Decreased Respiratory Rate; Fatigue; Loss of consciousness; Nausea; No Clinical Signs, Symptoms or Conditions; Vomiting

  MAUDE report 23335515 ↗
• MalfunctionOct 15, 2025Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE/SHUNT. IT WAS REPORTED THAT THE SHUNT CHAMBER COULD NOT BE VACUUMED. THE PROCEDURE WAS COMPLETED WITH BACKUP 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 23278959 ↗
• InjuryAug 28, 2025Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE/SHUNT. IT WAS REPORTED THAT 1 DAY AFTER THE OPERATION, THE PATIENT WAS STILL IN A SEIZURE BECAUSE THE CEREBROSPINAL FLUID (CSF) DID NOT COME OUT. THIS WAS CHECKED WITH A CT SCAN. THE DOCTOR THEN RE-DID THE OPERATION USING ANOTHER MANUFACTURER'S DEVICE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: Convulsion/Seizure

  MAUDE report 22911351 ↗
• MalfunctionJul 22, 2025Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT/VALVE. IT WAS REPORTED THAT THE FAILURE WAS REGARDING THE ASPIRATION OF LIQUID FROM THE VENTRICULAR CATHETER TO THE VALVE. PRESSURE WAS APPLIED TO THE RESERVOIR OF THE VALVE TO ASPIRATE THE LIQUID, BUT IT NEVER REACHED THE RESERVOIR TO GO THROUGH TO THE LUMBOPERITONEAL CATHETER. BOTH CATHETERS WERE SUBJECTED TO PRIMING TESTS AND WERE FOUND TO BE FINE; THEY WERE NOT BLOCKED OR LACERATED. AFTERWARD, THE CATHETERS WERE TESTED WITH A SYRINGE TO CHECK THE FLOW OF LIQUID AND SIMILARLY DID NOT PRESENT ANY FAILURES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22567328 ↗
• MalfunctionJul 22, 2025Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT/VALVE. IT WAS REPORTED THAT THE FAILURE WAS REGARDING THE ASPIRATION OF LIQUID FROM THE VENTRICULAR CATHETER TO THE VALVE. PRESSURE WAS APPLIED TO THE RESERVOIR OF THE VALVE TO ASPIRATE THE LIQUID, BUT IT NEVER REACHED THE RESERVOIR TO GO THROUGH TO THE LUMBOPERITONEAL CATHETER. BOTH CATHETERS WERE SUBJECTED TO PRIMING TESTS AND WERE FOUND TO BE FINE; THEY WERE NOT BLOCKED OR LACERATED. AFTERWARD, THE CATHETERS WERE TESTED WITH A SYRINGE TO CHECK THE FLOW OF LIQUID AND SIMILARLY DID NOT PRESENT ANY FAILURES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22567089 ↗
• MalfunctionJun 10, 2025Complete Blockage; Mechanical Jam; Complete Blockage; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT THE INLET VALVE WAS BLOCKED INTRA-OPERATIVELY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22175882 ↗
• MalfunctionMay 8, 2025Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THE VALVE WAS FAULTY BECAUSE WHEN PRESSING THE VALVE IN, WATER DID NOT FLOW. THE VALVE WAS REPLACED WITH A NEW ONE WHICH WATER FLOWED WITH THE VENTRICULAR AND PERITONEAL CATHETERS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21987554 ↗
• MalfunctionJan 2, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT THE CATHETER BROKE OFF WHEN PREPARING FOR USE. THE PROCEDURE WAS COMPLETED WITH BACKUP 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 21054243 ↗
• MalfunctionNov 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT THERE WAS A DEFECT. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683140 ↗
• MalfunctionNov 7, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT DURING THE VENTRICULOPERITONEAL SHUNT SURGERY, THE DISTAL TUBE WAS BROKEN INTO TOW PIECES WITHOUT USING THEM. ANOTHER SHUNT WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630247 ↗
• MalfunctionMay 3, 2024Infusion or Flow Problem; Infusion or Flow Problem

  (B)(6) 2024 MPXR 1177666 (FOR, HCP, DIST): MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT FOR A NON-COMMUNICATING HYDROCEPHALUS SPACE-OCCUPYING LESION (SOL), RIGHT CEREBELLOPONTINE ANGLE (CPA), SUSPECTING VESTIBULAR SCHWANNOMA PROCEDURE . IT WAS REPORTED THAT BEFORE USE/INSTALLED, THE NURSE TESTED THE VALVE, BUT INSTEAD OF PUMPING WATER, ONLY THE AIR WAS COMING OUT OF THE VALVE. THIS WAS TRIED SEVERAL TIMES. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS FROM ANOTHER HOSPITAL. THERE WAS A PROCEDURE DELAY OF 180 MINUTES. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19237782 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K831678. 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