N/A 41101Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000028039), received between Dec 18, 2020 and Jul 30, 2026 — classified as 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Insufficient Device Problem Information

  Medtronic received information regarding an adjustable shunt. It was reported that the shunt was implanted on (b)(6) 2024. The shunt failed to function for hydrocephalus spinal fluid drainage and was successfully replaced on (b)(6) 2025.

  Patient problems: Ambulation or Postural Difficulties; Cognitive Changes; Headache; Incontinence; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 50083078 ↗
• MalfunctionDec 17, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT UPON OPENING THE VENTRICULAR CATHETER, IT WAS FOUND THAT THE TIP OF THE CATHETER WAS BROKEN AND UNFIT FOR USE. IN ORDER TO AVOID INTERRUPTING THE SURGICAL PROCEDURE, IT WAS NECESSARY TO OPEN AN EXTERNAL VENTRICULAR DRAINAGE CATHETER FOR IMMEDIATE REPLACEMENT. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829890 ↗
• MalfunctionOct 22, 2025Disconnection; Device Misassembled During Manufacturing /Shipping; Disconnection; Device Misassembled During Manufacturing /Shipping

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT ON (B)(6) 2025, DURING A NEUROSURGICAL PROCEDURE, THE VENTRICULAR-END CATHETER OF THIS PRODUCT WAS REQUIRED. THE CATHETER AND ITS ACCESSORIES SHOULD HAVE BEEN TIGHTLY ASSEMBLED IN THE PRODUCT PACKAGING. HOWEVER, AFTER OPENING THE INNER PACKAGING, THE ACCESSORIES WERE NOT SECURELY ATTACHED TO THE CATHETER, CAUSING THE ACCESSORIES TO ACCIDENTALLY FALL OFF AND BECOME CONTAMINATED, MAKING THEM UNUSABLE. THE PRODUCT WAS REPLACED, AND THE SURGERY CONTINUED WITHOUT ANY ADVERSE EFFECT ON THE PATIENT. IT WAS NOTED THAT THE TREATMENT WAS DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357728 ↗
• MalfunctionDec 14, 2023Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT WHEN THE VENTRICULAR CATHETER WAS INSTALLED AND STARTED TO BE INSERTED INTO THE BRAIN, THE CEREBROSPINAL FLUID (CSF) DID NOT COME OUT. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. THERE WAS A PROCEDURE DELAY OF 30 MINUTES. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18324295 ↗
• InjuryNov 30, 2023Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A HYDROCEPHALUS VALVE. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT WAS TREATED WITH POST-TRAUMATIC VENTRICULOPERITONEAL SHUNT SURGERY. THE PATIENT DEVELOPED SEVERE HYDROCEPHALUS HALF A YEAR AFTER THE OPERATION. THE PATIENT WENT TO THE HOSPITAL FOR FOLLOW-UP CONSULTATION. THE DOCTOR IN CHARGE DETERMINED THAT THE SHUNT VALVE WAS FAULTY AND URGENTLY REPLACED THE SHUNT PARTS. AFTER THE SURGERY, THE PATIENT'S HYDROCEPHALUS CONDITION WAS SIGNIFICANTLY IMPROVED.

  Patient problems: Insufficient Information

  MAUDE report 18236542 ↗
• InjuryOct 31, 2023Complete Blockage; Complete Blockage

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL UNDER OBSERVATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18039527 ↗
• MalfunctionMar 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT DURING PROCEDURE THERE WAS A LEAK. THE PROCEDURE WAS COMPLETED USING BACKUP PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 16502534 ↗
• MalfunctionAug 22, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT DEVICE. IT WAS REPORTED THAT THE PERITONEAL SHUNT TUBE BROKE DURING THE PROCEDURE. THERE WAS A DELAY OF 45 MINUTES DUE TO THE ISSUE, AND IT WAS CONFIRMED THAT THERE WERE NOT PARTS LEFT INSIDE THE PATIENT. THE ISSUE WAS COMPLETED WITH BACK UP PRODUCTS. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15271448 ↗
• InjuryJul 19, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT AFTER THE SHUNT WAS IMPLANTED, THE PATIENT'S INTRACRANIAL PRESSURE AND SYMPTOMS OF HYDROCEPHALUS WERE NOT RELIEVED. MULTIPLE CLINICAL INTERVENTIONS WERE UNSUCCESSFUL, THE SHUNT WAS NOT SMOOTH. RE-OPERATION WAS REQUIRED TO CHECK WHETHER THE SHUNT WAS PATENCY. DURING THE SURGERY, IT WAS FOUND THAT THE BRAIN VENTRICLE END CATHETER WAS NOT SMOOTH. THE SHUNT WAS REPLACED WITH A NEW BRAIN VENTRICLE END CATHETER. THERE WAS NO REPORTED IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE VALVE WAS PRESSED, BUT THE SYMPTOMS OF INSUFFICIENT SHUNT WERE NOT RELIEVED. AFTER THE SURGERY, IT WAS FOUND THAT THE WHOLE SYSTEM OF THE SHUNT TUBE WAS NOT SMOOTH, AND IT WAS SUSPECTED THAT THE VALVE OF THE VENTRICLE OF THE BRAIN OR THE ABDOMINAL END BLOCKED THE PIPE. THE CAUSE OF THE EVENT WAS SUSPECTED TO BE DUE TO A STENOSIS INSIDE THE BODY OF THE SHUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15055649 ↗
• MalfunctionJun 24, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT DURING THE SHUNT PLACEMENT, THE HEALTH CARE PROFESSIONAL COULD NOT SLIDE THE CATHETER ON THE PASSIVE CATHETER INTRODUCER (PCI). THE SITE HAD TO TRY 3 CATHETERS BEFORE BEING ABLE TO PLACE THE VENTRICULAR CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14801058 ↗
• MalfunctionJun 13, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING CATHETERS USED DURING A PROCEDURE. IT WAS REPORTED THAT THE VENTRICULAR CATHETER WAS FRAGILE, CAUSING IT TO BREAK. IN ADDITION, THE PERITONEAL CATHETER WAS NOT SMOOTH, SO THE DRAINED LIQUID COULD NOT BE OPTIMIZED. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14680289 ↗
• MalfunctionMar 15, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER BEING USED IN A PROCEDURE. IT WAS REPORTED THAT THE CATHETER WAS BROKEN. DURING THE VENTRICULOPERITONEAL SHUNTED SURGERY IN THE OPERATING ROOM THE CATHETER WAS FOUND BROKEN DURING THE PROCESS OF IMPLANTING. THE HEALTH CARE PROFESSIONAL USED ANOTHER CATHETER OF THE SAME MODEL TO PERFORMED THE REMAINED OF THE PROCEDURE. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13772097 ↗
• MalfunctionJan 7, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A BROKEN IMPLANT. IT WAS REPORTED THAT THERE WAS A DEFECTIVE SHUNT, THE HOSE WAS BROKEN WHEN IMPLANTED TO THE PATIENT. THE DAMAGED PARTS WERE REPLACE WITH BACKUP PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13194626 ↗
• InjuryDec 18, 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: Hydrocephalus

  MAUDE report 11037281 ↗

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-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-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-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-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-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-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-1147-2009 · Feb 12, 2009 · Terminated
  Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 6 CM, Ref 27802D. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar po
• 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-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
• 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-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-1126-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782J. Sizes: 4.5 CM in length, REF (240) 27782J. Each catheter is provided in a sealed Tyvek pl

…and 16 more.