N/A 42314Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000028015), received between Jul 7, 2025 and Sep 11, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Fluid/Blood Leak

  Medtronic received information regarding a valve. It was reported that the proximal valve stem was leaking during a ventriculoperitoneal shunt placement. This was used on the patient but removed and replaced when it was noted to be leaking. The date of surgery was (b)(6)2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50734639 ↗
• MalfunctionJan 23, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THE DOCTOR WAS PLACING VENTRICULOPERITONEAL SHUNT, HOWEVER, IT STARTED LEAKING AS SOON AS THEY PUT IT IN. THE DOCTOR REMOVED IT AND PLACED A NEW ONE WITHOUT PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160260 ↗
• InjuryJul 7, 2025Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THE PATIENT WAS RECOVERING FROM A BRAIN TUMOR (MEDULLOBLASTOMA). IT WAS STATED THE DEVICE WAS EXTERNALIZED AS THE PATIENT WAS GOING THROUGH RADIOTHERAPY. THEY WERE GOING TO INTERNALIZE IT MAYBE ON (B)(6) 2025. THIS WAS CLARIFIED INDICATING THAT THE SHUNT WAS STILL IN PLACE AND THAT THE EXIT WAS OUT OF THE ABDOMEN TO A BAG. IT WAS INDICATED THE PATIENT HAD CEREBRAL MUTISM AND WAS UNABLE TO COMMUNICATE BUT SOMETIMES MAYBE SLIGHT HEAD NOD TO YES/NO QUESTIONS. THE PATIENT WAS ALSO HAVING PROBLEMS WITH OVER OR UNDER DRAINING AS THEY WERE HAVING SLIT VENTRICLES, THEN HUGE VENTRICLES. THEY HAVE NOT FOUND A DECENT DRAIN OPEN SCHEDULE. IT WAS INDICATED THAT THE PATIENT HAS HAD MULTIPLE POST OPERATIVE PROBLEMS. 10 WEEKS AFTER THE MEDULLOBLASTOMA WAS REMOVED, THE PATIENT WAS STILL MINIMALLY RESPONSIVE. EVERY CT SCAN SHOWED ENLARGED OR SLIT VENTRICLES. THE PATIENT NOW HAD MULTIPLE BLOOD CLOTS IN THEIR CEREBRAL VESSELS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22418507 ↗

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