NA 43103 (UDI 00643169466821)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00643169466821), received between Nov 30, 2016 and Jun 6, 2024 — classified as 14 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K792005); 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2024Break; Fracture; Infusion or Flow Problem; Break; Fracture; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO COMA. EXAMINATION REVEALED HYDROCEPHALUS. AFTER FOLLOW-UP, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT V-P (VENTRICULOPERITONEAL) SHUNT SURGERY. ON (B)(6) 2024, THE PATIENT SUDDENLY HAD CONVULSIONS ON THE LEFT LIMBS, ACCOMPANIED BY HEADACHES, AND WENT TO A LOCAL HOSPITAL FOR TREATMENT. THE DETAILS WERE UNKNOWN. LATER, THE ABOVE SYMPTOMS RECURRED, ACCOMPANIED BY A BRIEF LOSS OF CONSCIOUSNESS. HEAD CT SCAN SHOWED: RIGHT VENTRICLE ENLARGEMENT. HEAD MR SCAN SHOWED: RIGHT LATERAL VENTRICLE EXPANSION AND HYDROPS, RIGHT LATERAL VENTRICLE TOP LOCALIZED PROTRUSION. DIVERTICULUM TO BE EXAMINED. AROUND (B)(6) 2024, THE PATIENT DEVELOPED A SUBCUTANEOUS MASS ON THE RIGHT SIDE OF THE NECK, NO FEVER, HEADACHE, NAUSEA, VOMITING, ETC. FOR FURTHER DIAGNOSIS AND TREATMENT, THE PATIENT CAME TO OUR HOSPITAL FOR A FOLLOW-UP EXAMINATION ON (B)(6) 2024. THE HEAD CT SCAN SHOWED THAT THE RIGHT VENTRICLE OF THE BRAIN HAD CHANGED AFTER DRAINAGE SURGERY AND COMPARED WITH THE CT SCAN ON (B)(6) 2018, THE CT WAS SIMILAR. THE PATIENT WAS HOSPITALIZED ON (B)(6

  Patient problems: Cramp(s) /Muscle Spasm(s); Headache; Loss of consciousness

  MAUDE report 19476189 ↗
• InjurySep 10, 2021Fracture; Fracture

  IT WAS REPORTED THAT 2 YEARS AFTER SURGERY, THE CATHETER AT THE END OF THE ABDOMINAL CAVITY BROKE, AND THE BROKEN PART FELL INTO THE ABDOMINAL CAVITY. THE PATIENT EXPERIENCED DIZZINESS AND STOMACH PAIN. THE VENTRICULOPERITIONEAL SHUNT WAS PERFORMED AGAIN WHERE THE SHUNT WAS TAKEN OUT. IT WAS INDICATED THAT THE BROKEN PIECES THAT REMAINED INSIDE THE PATIENT'S BODY WERE RETRIEVED. THE PATIENT'S VITAL SIGNS WERE STABLE AND CONSCIOUS AFTER THE SURGERY.

  Patient problems: Abdominal Pain; Dizziness

  MAUDE report 12453404 ↗
• InjuryJul 7, 2021Disconnection; Fracture; Disconnection; Fracture

  IT WAS REPORTED THAT THE PATIENT RECEIVED A VENTRICULAR-ABDOMINAL SHUNT DUE TO HYDROCEPHALUS AND RECOVERED WELL AFTER THE OPERATION. ON (B)(6) 2021, THE PATIENT HAD SUDDEN DIZZINESS AND UNSTEADY WALKING ACCOMPANIED BY DECREASED VISION. THE PATIENT WENT TO THE EMERGENCY DEPARTMENT OF THE HOSPITAL. AFTER THEY WERE ADMITTED BY THE HOSPITAL FOR HOSPITALIZATION, THE SYMPTOMS WERE RELIEVED BY INFUSION OF MANNITOL. THE PATIENT'S PRESSURE OF THEIR SHUNT WAS ADJUSTED AND REDUCED AS WELL DURING THE HOSPITALIZATION WHICH THEIR CLINICAL SYMPTOMS IMPROVED IMMEDIATELY. AFTER DISCHARGE, THE SYMPTOMS RECURRED IN A SHORT TIME, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL AGAIN. AFTER THE SHUNT WAS ADJUSTED, THE PATIENT'S SYMPTOMS IMPROVED WITHIN A SHORT TIME AND THEN WORSENED AGAIN. CT REVIEW WAS PERFORMED, AND HYDROCEPHALUS WORSENED AND CONSCIOUSNESS REACTION GRADUALLY DETERIORATED. CT EXAMINATION OF THE HEAD, NECK, CHEST, ABDOMEN, AND PELVIS REVEALED THAT THE ABDOMINAL CAVITY END OF THE SHUNT WAS DISLOCATED. REPLACEMENT SURGERY OF THE VENTRICLE SHUNT WAS PERFORMED ON (B)(6) 2021, AND DURING THE OPERATION, IT WAS FOUND THAT THE ABDOMINAL END OF THE SHUNT WAS BROKEN. AFTER THE REPLACEMENT OF THE AB

  Patient problems: Ambulation or Postural Difficulties; Cognitive Changes; Dizziness; Visual Impairment

  MAUDE report 12129815 ↗
• MalfunctionJan 31, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT WHEN THE VALVE WAS TESTED, SALINE DID NOT FLOW OUT FROM THE PERITONEAL END WHEN THE SURGEON LIFTED UP THE VENTRICULAR CATHETER, WHICH WAS DIPPED INSIDE THE SALINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9655985 ↗
• InjuryJan 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE VALVE WAS CONNECTED IN THE PATIENT TO THE VENTRICLE AND ABDOMINAL CATHETER. IT WAS THEN FOUND THAT THE VALVE WAS DAMAGED/BROKEN AND LEAKING. AS A RESULT, THE SURGERY COULD NOT BE CARRIED OUT, AND ALL THE DEVICES WERE REMOVED. IT WAS STATED THAT THERE WAS A PROCEDURE DELAY OF 60 MINUTES. THE SKULL WAS CLOSED, AND THEY WERE AWAITING BACK UP PRODUCTS FOR SURGERY AGAIN. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT HAD AN ADDITIONAL SURGERY TO IMPLANT ANOTHER DEVICE ON A DIFFERENT DATE. IT WAS INDICATED THAT THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9611820 ↗
• MalfunctionMar 20, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE CATHETER WAS BROKEN. THERE WAS NO INTERVENTION PERFORMED OR PLANNED AS THE DEVICE DID NOT HAVE CONTACT WITH THE PATIENT. AS A RESULT THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8436441 ↗
• InjuryFeb 18, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE CATHETER RUPTURED AT THE THIRD THORACIC VERTEBRAE, AFFECTING CEREBROSPINAL FLUID DRAINAGE. AS A RESULT THE PATIENT EXPERIENCED INCREASED INTRACRANIAL PRESSURE AND HEADACHES. THE FRACTURE WAS "FLUSH" AND THE PATIENT'S SKIN DID NOT SHOW ANY TRAUMA. IT WAS STATED THERE WAS NO TRAUMATIC INCISION ON THE SURFACE OF THE SKIN. THE ISSUE WAS PRESUMED TO BE DUE TO A PIPELINE QUALITY PROBLEM. THE PATIENT'S CONDITION WAS TEMPORARILY STABLE, BUT THE INTRACRANIAL PRESSURE WAS HIGH. IT WAS PLANNED TO HAVE A SECOND OPERATION FOR THE PATIENT ON (B)(6) 2019 WHERE THE OLD CATHETER AND VALVE WOULD BE REMOVED AND REPLACED WITH NEW PRODUCT OF THE SAME MODEL.

  Patient problems: Headache

  MAUDE report 8348204 ↗
• MalfunctionAug 5, 2018Obstruction of Flow; Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE 4 SLIT OPENINGS OF THE CATHETER WERE FOUND TO BE OBSTRUCTED DURING TESTING PRIOR TO IMPLANT. IT WAS STATED THE 3 OF THE 4 SLIT OPENINGS WERE OPENED WITH A SYRINGE, BUT THE FOURTH SLIT OPENING COULD NOT BE OPENED. THE CATHETER WAS NEVER IMPLANTED AND REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7750300 ↗
• InjuryJul 14, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT FOLLOWING IMPLANT, THE DOCTOR FOUND THAT THE SHUNT DIVERSION WAS POOR. ACCORDING TO THE REPORT, THE DOCTORS THOUGHT THERE WAS A PROBLEM WITH THE SHUNT, SO IT WAS REPLACED. REPORTEDLY, THERE WAS NO INJURY TO THE PATIENT AND THEY WERE IN NORMAL CONDITION.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6715543 ↗
• InjuryJul 14, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE VALVE WAS NOT FUNCTIONING AND THERE WAS NO DRAINAGE OF CEREBROSPINAL FLUID. IN AD DITION, THERE WAS A SUTURE LEAK. ACCORDING TO THE REPORT, THE SHUNT WAS COMPLETELY REMOVED AND WOULD BE REPLACED WITH A DIFFERENT SHUNT AFTER TWO WEEKS. REPORTEDLY, THERE WAS NO HARM OR INJURY.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6715529 ↗
• MalfunctionJul 10, 2017Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE CATHETER WALL WAS FOUND TO BE BROKEN PRIOR TO USE. ACCORDING TO THE REPORT, THE CATHETER WAS NEVER IMPLANTED AND WAS REPLACED. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6696936 ↗
• InjuryJun 21, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD BEEN OUT OF THE HOSPITAL, BUT IT WAS NOT CLEAR WHAT THEIR CURRENT STATUS WAS.

  Patient problems: Vomiting

  MAUDE report 6658347 ↗
• InjuryJun 20, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STABLE AFTER THE DEVICE WAS REPLACED AND THE HYDROCEPHALUS SYMPTOMS WERE ABATED.

  Patient problems: Hydrocephalus; Therapeutic Response, Decreased

  MAUDE report 6654015 ↗
• InjuryJun 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT DEVELOPED AN INFECTION. ACCORDING TO THE REPORT, IT WAS UNKNOWN IF THE CATHETER WAS REPLACED. REPORTEDLY, THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: Unspecified Infection

  MAUDE report 6648379 ↗
• InjuryMay 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE CATHETER WAS REMOVED AS PART OF A SHUNT REVISION.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6596217 ↗
• 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 6531974 ↗
• InjuryApr 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT WAS IMPLANTED ON (B)(6) 2017 DUE TO CEREBRAL HEMORRHAGE AND HYDROCEPHALUS. ACCORDING TO THE REPORT, IN (B)(6) AN ¿EPIDURAL EFFUSION¿ WAS NOTED AND THE PATIENT WAS IN A COMA. IT WAS REPORTEDLY UNKNOWN IF A DEVICE RELATED ISSUE CAUSED OR CONTRIBUTED TO THE PATIENT¿S SYMPTOMS OR COMA. THE PATIENT¿S CURRENT STATUS WAS REPORTED AS ¿WELL¿ AS OF (B)(6) AND THE DEVICE REMAINED IMPLANTED.

  Patient problems: Coma

  MAUDE report 6495623 ↗
• MalfunctionApr 7, 2017Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE CATHETER WAS FOUND TO BE RUPTURED DURING IMPLANTATION. ACCORDING TO THE REPORT, THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6474243 ↗
• InjuryNov 30, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT WAS IMPLANTED DUE TO A SUBARACHNOID HEMORRHAGE. ACCORDING TO THE REPORT, SIX DAYS AFTER IMPLANT, THE PATIENT HAD DEVELOPED AN INFECTION AND WAS IN A COMA. THE SYSTEM WAS EXPLANTED. AS OF EARLY (B)(6), THE PATIENT STILL HAD AN INFECTION, WAS RECEIVING ANTI-INFECTION TREATMENT AND IN A COMA.

  Patient problems: Coma; Therapeutic Response, Decreased; Unspecified Infection

  MAUDE report 6136818 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K792005. One submission often covers many models, so check the product and lot details in each record.

• Z-0397-2014 · Nov 18, 2013 · Terminated
  CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Reg