NA 42324Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169466944), received between Jun 16, 2017 and Jun 1, 2020 — classified as 3 injuries.

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

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryJun 1, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE PATIENT WITH A DIAGNOSIS OF HYDROCEPHALUS WAS TAKEN TO SURGERY ON (B)(6) 2020 FOR PLACEMENT OF A VENTRIC ULOPERITONEAL SHUNT. ON (B)(6) 2020, DURING TOUCH TIME, THE PARENTS NOTED THE DRESSING OVER THE REPAIR SITE TO BE SATURATED. THE NEUROSURGERY TEAM WAS NOTIFIED, AND THE PATIENT WAS EXAMINED. PER NOTES, THE SHUNT WAS TAPPED WITH 0.5 MLS OBTAINED; SPECIMEN WAS SENT TO LAB FOR CULTURE. THE PATIENT WAS TAKEN TO SURGERY ON (B)(6) 2020 FOR REMOVAL OF THE PREVIOUS VENTRICULOPERITONEAL SHUNT IN IT'S ENTIRETY WITH REPLACEMENT; LUMBAR MYELOMENINGOCELE WOUND REVISION. PER OPERATIVE NOTE, UPON REMOVAL OF THE RESERVOIR OF THE OLD SHUNT, THERE WAS NO FLOW FROM THE PROXIMAL VENTRICULAR CATHETER. THE DISTAL SYSTEM WAS INTERROGATED, AND THERE WAS INTERMITTENT DISTAL FLOW. THE PATIENT REMAINED IN PATIENT AT THE TIME OF THE REPORT AND PER NOTES WAS DOING WELL.

  Patient problems: Fluid Discharge

  MAUDE report 10105917 ↗
• InjuryDec 4, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE VALVE WAS EXPLANTED DUE TO OVERDRAINAGE. IT WAS NOT KNOWN IF THERE WERE ANY EXTERNAL/ENVIRONMENTAL/PATIENT FACTORS THAT MAY HAVE LED TO THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8131118 ↗
• InjuryJun 16, 2017Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT DEVELOPED AN INFECTION. ACCORDING TO THE REPORT, THE VALVE WAS REPLACED. REPORTEDLY, THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: Unspecified Infection

  MAUDE report 6648375 ↗

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