NA 42314Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169466487), received between Jan 6, 2017 and Jun 13, 2019 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. 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.

• InjuryJun 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT PRESENTED WITH VOMITING AND ABDOMINAL PAIN AND WITHOUT HEADACHES OR CHANGE IN MENTAL STATUS. THEY WERE FOUND TO HAVE A SMALL-BOWEL OBSTRUCTION AND WAS BROUGHT TO THE OPERATING ROOM TO DETERMINE THE CAUSE OF THE BOWEL OBSTRUCTION AND TO RULE OUT SHUNT INFECTION. THE PATIENT HAD A LAPAROTOMY WHERE 2 PIECES OF THE VENTRICULOPERITONEAL (VP) SHUNT TUBING WERE EXTERIORIZED. ONE WAS DRIPPING CEREBROSPINAL FLUID, AND THE OTHER WAS WITH NO EVIDENCE OF ANY DRAINAGE. THE DOCTOR OBTAINED A STAT CEREBROSPINAL GRAM STAIN AND CULTURE TO EVALUATE FOR INFECTION. THE CEREBROSPINAL FLUID SENT FROM THE OPERATION REVEALED NO EVIDENCE OF INFECTION, WITH A NEGATIVE GRAM STAIN AND CLEAN PROFILE; HOWEVER, ON THE MORNING OF (B)(6) 2017, THE CEREBROSPINAL FLUID FROM THAT SURGERY BEGAN GROWING STAPHYLOCOCCUS. THE PATIENT'S LEFT PARIETAL VP SHUNT WAS REMOVED AND REPLACED WITH A LEFT PARIETAL EXTERNAL VENTRICULAR DRAIN. THEY ALSO UNDERWENT IV ANTIBIOTIC THERAPY AFTER THE PICC LINE WAS PLACED AS WELL AS REQUIRED A PLATELET TRANSFUSION PRIOR TO THE PROCEDURE.

  Patient problems: Abdominal Pain; Bacterial Infection; Vomiting

  MAUDE report 8697898 ↗
• InjuryJun 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION POTENTIALLY FROM THE SHUNT. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT'S CURRENT STATUS WAS ALIVE-NO INJURY.

  Patient problems: Unspecified Infection

  MAUDE report 7593159 ↗
• MalfunctionAug 24, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE DIDN'T WORK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6818008 ↗
• MalfunctionJan 6, 2017Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE WAS NOT DRAINING PROPERLY INTRA-OPERATIVELY. ACCORDING TO THE REPORT, THE DEVICE WAS SUCCESSFULLY REPLACED DURING THE PROCEDURE. REPORTEDLY, THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6229376 ↗

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