N/A 45103Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000027759), received between Nov 28, 2022 and Nov 28, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Disconnection” (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.

• MalfunctionNov 28, 2022Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THE DRAINAGE TUBE OF LEFT VENTRICLE OF THE BRAIN WAS PLACED IN THE OPERATING ROOM, AND THE DRAINAGE WAS SMOOTH AFTER OPERATION. 10-22 22:30 THE JUNCTION OF THE DRAINAGE TUBE OUTSIDE THE VENTRICLE OF THE PATIENT FELL OFF. REMOVED THE SHORT END OF THE SHORT TUBE AND CONNECTED THE TWO ENDS DIRECTLY. THE CAUSE OF THE EVENT WAS REPORTED TO LIKELY BE DUE MATERIAL ISSUE OF THE DEVICE. THE REPORTED IMPACT TO PATIENT WAS AN INCREASED RISK OF INFECTION. (B)(6) 2022. REP: NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15869224 ↗

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