NA 41101Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00643169466500), received between Nov 30, 2016 and Jun 6, 2024 — classified as 16 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

31 other recalls cover devices cleared under the same FDA submission (K792007); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 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 JANUARY 2, 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 FEBRUARY 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 MARCH 1, 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 JANUARY 3, 2018, THE CT WAS SIMILAR. THE PATIENT WAS HOSPITAL

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

  MAUDE report 19476205 ↗
• MalfunctionNov 11, 2021Complete Blockage; Complete Blockage

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT WAREHOUSE ENVIRONMENT WERE ALL IN COMPLIANCE WITH THE RULES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12797355 ↗
• 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 9655978 ↗
• InjuryJan 24, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH HYDROCEPHALUS IN OR ABOUT (B)(6) 2018. AFTER GOING VARIOUS OPTIONS, THEIR MEDICAL TEAM RECOMMENDED SURGERY AND THE INSERTION OF A SHUNT TO DRAIN FLUID FROM THEIR HEAD. THE SURGERY TOOK PLACE THE MORNING OF (B)(6) 2019. THE PROCEDURE TOOK APPROXIMATELY 2 HOURS, DURING WHICH A VENTRICLE AND PERITONEAL CATHETER FROM THE MANUFACTURER WERE INSERTED IN ACCORDANCE WITH STANDARD PRACTICE AND PROCEDURE. WHILE IN POST-OP CARE THE SAME DAY AS THE SURGERY, THE PATIENT BECAME LETHARGIC AND LOST CONSCIOUSNESS. THEY WERE SUBSEQUENTLY TAKEN FOR A CT SCAN WHERE IT WAS DISCOVERED THAT THE SHUNT WAS DRAINING FLUID FAR TOO RAPIDLY. AS A RESULT, THEY WERE RUSHED INTO A FURTHER SURGERY WHERE THE SHUNT WAS CLAMPED OFF TO PREVENT FURTHER DRAINAGE, HOWEVER, THAT WAS NOT BEFORE THE PATIENT SUFFERED WHAT APPEARED TO BE SIGNIFICANT BRAIN DAMAGE INCLUDING, BUT NOT LIMITED TO, AN INABILITY TO WALK, PARALYSIS OF THEIR VOCAL CORDS, AN INABILITY TO EAT AMONG OTHER THINGS.

  Patient problems: Ambulation or Postural Difficulties; Dysphasia; Lethargy; Loss of consciousness; No Code Available

  MAUDE report 9628323 ↗
• InjuryJan 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 9624878 ↗
• 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 9611797 ↗
• MalfunctionJul 1, 2019Fracture; Fracture

  INFORMATION WAS RECEIVED REGARDING A PATIENT UNDERGOING CSF MANAGEMENT SURGERY. IT WAS REPORTED THAT THE CATHETER HAD RUPTURED. NO BROKEN PIECES REMAINED INSIDE THE PATIENT'S BODY. AS A RESULT, THE DEVICE WAS REPLACED AND THE PROCEDURE COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8750873 ↗
• InjuryApr 26, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE DEVICE WAS DAMAGED SINCE THERE WAS A CATHETER OBSTRUCTION. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8558143 ↗
• InjuryMar 18, 2019Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED A REPORT THAT THE CATHETER WAS EMBRITTLED AND CRACKED WHEN THE SURGEON PLACED IT. AS A RESULT THE DEVICE WAS REPLACED WITH ANOTHER CATHETER. IT WAS NOTED THAT THE SURGEON WAS TRYING TO PLACE THE CATHETER INTO THE VENTRICULAR FOR CSF DRAINAGE. NO BROKEN PIECES REMAINED INSIDE THE PATIENT. THERE WAS NO DELAY IN SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8430113 ↗
• MalfunctionFeb 28, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THERE WAS A CATHETER OBSTRUCTION. IT WAS STATED THAT THE FIRST TIME THEY TESTED THE CATHETER INTRA-OPERATIVELY, IT WOULDN'T WORK. THE ASSISTANT PROBABLY TRIED TWO OR THREE TIMES BEFORE THE WATER CAME OUT. THE CATHETER WAS PLACED IN THE VENTRICLE, BUT THERE WAS NO CEREBROSPINAL FLUID OUTFLOW. THERE WAS NO PROBLEM AFTER REPLACING THE CATHETER. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8378558 ↗
• InjuryFeb 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AS PART OF A SHUNT REMOVAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8348223 ↗
• MalfunctionJan 23, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE PRE-OPERATIVE TEST, THE CATHETER WAS FOUND TO BE LEAKING. THE CATHETER WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7212961 ↗
• InjuryJan 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF THE CATHETER, THERE WAS WOUND LEAKAGE. IT WAS DETERMINED THAT THE VENTRICLE HAD BECOME INFECTED. THE CATHETER WAS REMOVED FROM THE PATIENT AND BOTH DEBRIDEMENT AND A BACTERIAL CULTURE WERE DONE. MEDICATION WAS ALSO ADMINISTERED TO CONTROL THE INTRACRANIAL INFECTION. THE CATHETER WAS TO BE REPLACED IN THE FUTURE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 7175016 ↗
• InjuryNov 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE CATHETER WAS REMOVED AS PART OF A REPLACEMENT PROCEDURE. THE PATIENT HAD BEEN IMPLANTED FOR HYDROCEPHALUS.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 7014597 ↗
• InjuryNov 1, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THE PATIENT WAS EXPERIENCING HEADACHES AND NAUSEA. THE SURGEON REPORTEDLY OBSERVED DISTAL CATHETER OBSTRUCTION. THE CATHETER WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT. THE PATIENT'S MEDICAL HISTORY INCLUDED STENOSIS OF AQUEDUCT OF SILVIUS DIAGNOSED IN 1984, AND A CEREBROSPINAL FLUID INFECTION WITH STAPHYLOCOCCUS EPIDERMIDIS IN (B)(6) 2017, WHICH WAS TREATED WITH ANTIBIOTICS AND EXTERNAL DRAINAGE. THE VALVE SYSTEM WAS IMPLANTED WHEN THE INFECTION WAS RESOLVED.

  Patient problems: Headache; Nausea; Therapeutic Response, Decreased

  MAUDE report 6993881 ↗
• 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 6715523 ↗
• 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 6653993 ↗
• 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 6648371 ↗
• 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 6596219 ↗
• 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 6495624 ↗
• MalfunctionDec 22, 2016Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT PRIOR TO IMPLANTING THE PRODUCT, IT WAS OBSERVED THAT THERE WERE NO LATERAL HOLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6199982 ↗
• 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 6136831 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K792007. 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
• 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
• Z-1131-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782D. Sizes: 7 CM in length, REF (240) 27782D. Each catheter is provided in a sealed Tyvek plas
• 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-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-1143-2009 · Feb 12, 2009 · Terminated
  Snap Shunt Ventricular Catheter, Standard, with BioGlide, 11 CM, Ref 27708J 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-1151-2009 · Feb 12, 2009 · Terminated
  Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 10 CM, Ref 27802H. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar p
• 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-1139-2009 · Feb 12, 2009 · Terminated
  Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27708E. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The
• Z-1124-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782L. Sizes: 3 CM in length, REF (240) 27782L. 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-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-1125-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782K. Sizes:5.5CM in length, REF (240) 27782K. Each catheter is provided in a sealed Tyvek plas
• 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

…and 16 more.