N/A 22063Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000028060), received between Jun 3, 2022 and Jun 3, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2022Infusion or Flow Problem; Infusion or Flow Problem

  THE PATIENT CALLED TO REPORTED THAT THEY HAD SEVEN REVISIONS WITH THEIR SHUNT VALVE. THEY HAVE EXPERIENCED INTERNAL LACERATIONS, FROZEN SHOULDER, ADHESIONS, ABDOMINAL WOULD THAT WOULD NEVER HEAL, CSF LEAKAGE, HEADACHES AND INCREASED PULSE RATE. THEY REPORT THAT THEY COULD FEEL SHARP EDGES FROM THE DEVICE IN THEIR ABDOMEN. WITH EACH REVISION THE HEALTH CARE PROFESSIONAL WOULD NOTE THAT THE DEVICE WAS DEFECTIVE, THE POP OFF WOULD NOT FUNCTION CORRECTLY. WHEN THEY SHOULD HAVE 25ML OF PRESSURE RELIEF, THEY WOULD GET 3ML. THEY STATED THAT THEY WERE BEDREST FOR A YEAR AND WERE SO DEPRESSED THAT PRIOR TO THEIR LAST SURGERY THAT THEY ASKED THE HCP TO LET THEM DIE ON THE TABLE. THEY NO LONGER FEEL SUICIDAL DUE TO COMPLETE REMOVAL OF THE SYSTEM AND STATE THAT THEY LIFE HAS IMPROVED BUT, THEY WILL NEVER BE THE SAME. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT STATING THAT THEY CONTINUE TO HAVE NEUROLOGICAL PROBLEMS/DEFICITS CAUSED BY IMPLANTED DEVICES.

  Patient problems: Arrhythmia; Cerebrospinal Fluid Leakage; Cognitive Changes; Depression; Headache; Impaired Healing; Laceration(s); Loss of Range of Motion

  MAUDE report 14591457 ↗

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 ULT