NA 9040 ERecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00643169466340), received between Apr 27, 2017 and Aug 25, 2021 — classified as 1 death, 15 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PERITONEAL CATHETER BROKE WHEN THE DOCTOR PULLED UP AND WANTED TO CONNECT TO THE VALVE. THE DOCTOR CHANGED THE CATHETER FROM A CSF FLOW CONTROL SHUNT KIT AS WELL AS A BURR HOLE SHUNT KIT; HOWEVER, THE PERITONEAL CATHETERS BROKE TOO. THE DOCTOR USED ANOTHER NEW PERITONEAL CATHETER, AND IT WORKED. AS A RESULT, THE PROCEDURE WAS DELAYED 2 HOURS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12367361 ↗
• MalfunctionMar 8, 2021Break; Fracture; Break; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11441041 ↗
• DeathMar 5, 2021Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION IN THE BRAIN AS SEEN POST SHUNT IMPLANT PROCEDURE. IT IS UNKNOWN IF THERE WAS ANY INTERVENTION PLANNED, IF THE PRODUCT WAS DAMAGED, OR HOW THE PROCEDURE WAS COMPLETED. THE PATIENT IS NOTED TO BE DECEASED.

  Patient problems: Unspecified Infection

  MAUDE report 11424176 ↗
• MalfunctionDec 16, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE AS THEY WERE NOT EXPECTED SINCE THE EVENT OCCURRED DURING THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9475871 ↗
• MalfunctionNov 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CATHETER HAD LOOSE ELASTICITY. THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE SURGERY. 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 9298494 ↗
• MalfunctionNov 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CATHETER HAD LOOSE ELASTICITY. THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE SURGERY. 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 9298481 ↗
• MalfunctionNov 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CATHETER HAD LOOSE ELASTICITY. THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE SURGERY. 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 9298462 ↗
• MalfunctionOct 7, 2019Break; Break

  IT WAS REPORTED THAT DURING THE OPERATION, THE DOCTOR DISCOVERED A HOLE IN THE SHUNT RESERVOIR. IT WAS NOTED THAT THE OPERATION WAS POSTPONED, AND THE PATIENT WAS SAFE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9163551 ↗
• MalfunctionSep 6, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A LEAK WAS DETECTED WHILE CHECKING THE SHUNT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8971542 ↗
• MalfunctionMar 24, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE VALVE WAS BLOCKED PRE-OPERATIVELY. 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 8446691 ↗
• MalfunctionMar 18, 2019Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS A LEAK AT THE VALVE DUE TO A BROKEN SHUNT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8429820 ↗
• MalfunctionOct 17, 2018Break; Break

  IT WAS REPORTED THAT UPON OPENING THE IMPLANT, IT WAS FOUND THAT THE PERITONEAL END OF THE SHUNT WAS BROKEN. IT WAS NOTED THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7973768 ↗
• MalfunctionMar 14, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT NO CEREBROSPINAL FLUID (CSF) FLOWED INTO THE RESERVOIR WHEN THE CATHETER AND VALVE WERE IMPLANTED. THE SURGEON SUSPECTED THE VALVE WAS FAULTY/SPOILT AND REPLACED THE VALVE. IT WAS UNKNOWN IF ANY SYMPTOMS WERE ASSOCIATED WITH THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7339074 ↗
• MalfunctionNov 28, 2017Break; Break

  IT WAS REPORTED THE PERITONEAL CATHETER WAS BROKEN PRE-OPERATIVELY. THE DEVICE WAS TO BE REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7063324 ↗
• MalfunctionApr 27, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT WHEN THE HEALTHCARE PROFESSIONAL FLUSHED THE VALVE PREOPERATIVELY, IT WAS NOT WORKING. ACCORDING TO THE REPORT, THE INLET VALVE ONLY WOULD SUCK THE NORMAL SALINE BUT COULD NOT FLUSH. REPORTEDLY, THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6527815 ↗
• MalfunctionApr 27, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT WHEN THE HEALTHCARE PROFESSIONAL FLUSHED THE VALVE PREOPERATIVELY, IT WAS NOT WORKING. ACCORDING TO THE REPORT, THE INLET VALVE ONLY WOULD SUCK THE NORMAL SALINE BUT COULD NOT FLUSH. REPORTEDLY, THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6527739 ↗

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