N/A 43103Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00763000028305), received between Oct 4, 2021 and Sep 24, 2026 — classified as 5 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Infusion or Flow Problem

  Medtronic received information regarding an adjustable shunt. It was reported that after implantation of the flow-diverting device, testing revealed that it was not patent. After an intraoperative replacement with a new product, it became patent. There was a procedure delay of 30 minutes. The patient's status at the time of the report was alive- no injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882569 ↗
• MalfunctionApr 28, 2026Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT DURING IMPLANTATION, THE CATHETERS WERE PULLED, BUT IT WAS BROKEN OFF. ALL THE ITEMS IN THE SYSTEM (1 VALVE, 2 CATHETERS) WERE DISCARDED BY THE HOSPITAL. 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 25016146 ↗
• MalfunctionMar 16, 2026Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THE DOCTOR FOUND A LEAK/CRACK DURING THE PROCEDURE, AND REPLACED IT WITH A SPARE PRODUCT. THERE WAS A PROCEDURE DELAY OF 5 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24607217 ↗
• MalfunctionMar 16, 2026Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, A PHYSICIAN OBSERVED FLUID LEAKAGE FROM A WHITE CATHETER. A CRACK WAS IDENTIFIED UPON INSPECTION, AND THE DEVICE WAS REPLACED WITH A BACK UP PRODUCT. THERE WAS A PROCEDURE DELAY OF 5 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24607046 ↗
• MalfunctionJan 21, 2026Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT DURING THE SURGERY, THE DOCTOR FOUND ABNORMAL AND OBSTRUCTED DRAINAGE AFTER CONNECTING THE VALVE AND THE ABDOMINAL CATHETER. AFTER REPLACING THE VALVE AND CATHETER WITH NEW ONES, NORMAL FUNCTION WAS RESTORED. THERE WAS A PROCEDURE DELAY OF 30 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130998 ↗
• MalfunctionSep 17, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT ON (B)(6) 2024, WHEN USING THE CATHETER FOR A VENTRIC ULOPERITONEAL SHUNT SURGERY IN THE OPERATING ROOM, THE CATHETER WAS BROKEN. THE SURGERY WAS COMPLETED AFTER REPLACEMENT OF THE PRODUCT WITH THE SAME MODEL. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE NO-INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073128 ↗
• MalfunctionAug 5, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THE CATHETER BROKE WHEN PULLED USING A SPANNER. 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 22713861 ↗
• MalfunctionJun 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THE CATHETER WAS LEAKING. 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 22149018 ↗
• MalfunctionJan 2, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT DURING PREPARATION FOR USE, THE CARDIAC/PERITONEAL CATHETER BROKE OFF. THE DOCTOR USED ANOTHER CATHETER FOR BACKUP. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21054185 ↗
• MalfunctionDec 12, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT WHEN TRYING TO ATTACH THE PERITONEAL CATHETER, THE TUBE WAS BROKEN. 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 20912119 ↗
• MalfunctionNov 20, 2024Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THE DIRECTOR OPENED THE PACKAGE AND CHECKED THE PATENCY OF THE CATHETER. IT WAS FOUND THAT THE CATHETER WAS LEAKING AND DAMAGED SO IT COULD NOT BE USED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20733080 ↗
• MalfunctionNov 15, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT DURING INSERTION OF THE CATHETER TO THE PERITONEAL, THE CATHETER LACERATED. 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 20698582 ↗
• MalfunctionNov 15, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT DURING INSERTION OF THE CATHETER TO THE PERITONEAL, THE CATHETER LACERATED. 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 20698414 ↗
• MalfunctionJun 12, 2024Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT A VENTRICULOPERITONEAL SHUNT (VP) WAS PERFORMED ON (B)(6) 2024 WITH A DIAGNOSIS OF NON-COMMUNICATING HYDROCEPHALUS. ASEPSIS WAS CARRIED OUT USING BETADINE AND PHENACAINE INJECTION. THEN, INCISIONS WERE MADE LAYER BY LAYER AT THE INCISION MARKINGS IN THE CRANIAL AREA, FOLLOWED BY INCISIONS IN THE RIGHT HYPOCHONDRIUM AREA UNTIL THE FASCIA WAS VISIBLE. THEN A SPANNER WAS INSERTED FROM THE ABDOMEN TO THE CRANIUM. THE SHUNT TUBE WAS INSERTED FROM THE CRANIUM TOWARDS THE ABDOMEN AND CONNECTED TO THE VP SHUNT CHAMBER. AFTER CONNECTING, IT APPEARED THAT THE CEREBROSPINAL FLUID WAS NOT COMING OUT AT THE PROXIMAL END, BUT AT A PROXIMAL HOLE. THE HOLE WAS 5 CM FROM THE PROXIMAL END. 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 19519101 ↗
• MalfunctionMar 29, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT AFTER UNPACKING, THE CATHETER WAS FOUND TO BE BROKEN. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19002677 ↗
• InjuryNov 30, 2023Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A HYDROCEPHALUS VALVE. IT WAS REPORTED THAT ON MAY 12, 2023, THE PATIENT WAS TREATED WITH P OST-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 18236629 ↗
• 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 18039553 ↗
• MalfunctionAug 9, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THE PACKAGE WAS OPENED AND THE PRODUCT TUBE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17487418 ↗
• InjuryJun 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT DURING A VENTRICULOPERITONEAL SHUNT SURGERY ON (B)(6) 2023, THE SUBCUTANEOUS TUNNEL WAS COMPLETED WITH A CLEANING ROD. WHEN THE ABDOMINAL END CATHETER WAS PLACED, IT WAS FOUND THAT THERE WAS LIQUID LEAKING FROM THE ANTI-SIPHON CHAMBER OF THE VALVE AND AT THE SITE NEAR THE FISSURE OPENING OF THE ABDOMINAL END CATHETER. THE VALVE AND THE CATHETER WERE REMOVED AND REPLACED WITH A DIFFERENT DEVICE. THERE WAS A REPORTED DELAY OF 60 MINUTES. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17101954 ↗
• InjuryMar 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THE VALVE WAS LEAKING LIQUID AFTER THE ADULT ADJUSTABLE PRESSURE SHUNT WAS CONNECTED, AND THE VALVE WAS REPLACED. THE ORIGINAL ABDOMINAL CAVITY END COULD NOT MEET THE CONNECTION REQUIREMENTS OF THE REPLACEMENT VALVE DUE TO CUTTING, SO THE ABDOMINAL CAVITY END WAS ALSO REPLACED. THERE WAS A SURGICAL DELAY OF 40 MINUTES.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16628950 ↗
• MalfunctionMar 20, 2023Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED WHEN THE CATHETER WAS TESTED BEFORE THE PROCEDURE, IT WAS FOUND THERE WAS A LEAK IN THE HOSE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16572946 ↗
• 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 16502330 ↗
• MalfunctionJan 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT DEVICE. IT WAS REPORTED THE SYSTEM WAS NOT SHUNTED SMOOTHLY DURING SURGERY. THE FOLLOW-UP INSPECTION FOUND THAT THE VALVE LEAKED THE LIQUID; THEREFORE, IT WAS REQUESTED TO BE REPLACED. THE DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. THE ISSUE WAS FOUND PRE-IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16121234 ↗
• MalfunctionDec 20, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THE CATHETER WAS BROKEN WHEN IT WAS IMPLANTED. THERE WAS NO REPORTED KNOWN REASON FOR THE EVENT. THE ISSUE CAUSED A 1 HOUR DELAY, AND THE PART WAS REPLACED TO FINISH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16014566 ↗
• MalfunctionOct 31, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED DURING THE SHUNT OPERATION, WHEN THE DEVICE WAS FINISHED CUTTING AND CONNECTING THE VALVE IT WAS FOUND THAT THERE WAS LIQUID LEAKING. CONTINUING TO CUT WOULD AFFECT THE INDWELLING LENGTH OF THE ABDOMINAL CAVITY END, SO THE SITE CHOSE TO REPLACE THE TUBE. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME AND NO REPORTED DELAY.

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

  MAUDE report 15698791 ↗

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