NA 9003 BRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169466401), received between May 10, 2018 and Dec 13, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K841442); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2021Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT BEING USED IN A PROCEDURE. IT WAS REPORTED THAT THE SHUNT WAS DEFECTIVE. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12987670 ↗
• 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 12367370 ↗
• MalfunctionNov 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ENVIRONMENTAL / EXTERNAL / PATIENT FACTORS THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE PROBLEM. THE PATIENT WAS CURRENTLY STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10817731 ↗
• MalfunctionMay 10, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PHYSICIAN PALPATED THE VALVE PRIOR TO IMPLANT AND DECIDED THAT IT WAS NOT WORKING PROPERLY. THE CAUSE OF THE ISSUE WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7503382 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K841442. 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