NA 42312Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169466494), received between Mar 10, 2017 and May 23, 2019 — classified as 2 injuries, 1 malfunction.

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

• InjuryMay 23, 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 WAS ADMITTED TO THE HOSPITAL FOR A WOUND LEAK AT THE SURGICAL SITE. THE DOCTOR REPAIRED THE SURGICAL INCISION. IT WAS NOTED THE WOUND WAS OVERSEWN WITH 3-0 MONOCRYL AT THE PATIENT'S BEDSIDE AFTER LOCAL INJECTION. IT WAS ALSO STATED THAT THERE WAS A SLIGHT WORSENING OF HYDROCEPHALUS; HOWEVER, THERE WAS NO EVIDENCE OF SHUNT MALFUNCTION. THE PATIENT WAS RELEASED THE FOLLOWING DAY, AND THE PARENTS WERE INSTRUCTED TO A PUMP REGIMEN OF 10 TIMES EVERY 2 HOURS.

  Patient problems: Fluid Discharge

  MAUDE report 8636152 ↗
• InjuryMay 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PATIENT'S MAY ADMISSION FOR CHEMOTHERAPY, THEIR SHUNT TUBING WAS VISIBLE, AND THERE WAS WOUND DEHISCENCE. ON (B)(6) 2017, THE PATIENT'S DOCTORS ATTEMPTED TO SUTURE IT BY CLOSING THE WOUND WITH NYLON SUTURE, BACITRACIN, AND ANTIBIOTICS WERE GIVEN. DUE TO WOUND HEALING PROBLEMS AND INFECTION AS A RESULT OF THE IMMUNOCOMPROMISED STATE OF AN INFANT ON CHEMOTHERAPY, THAT PROVED UNSUCCESSFUL. ON (B)(6) 2017, THE PATIENT WAS ADMITTED TO REVISE THEIR SHUNT DUE TO FURTHER SHUNT COMPLICATIONS. THE SHUNT WAS TAPPED AT THE PATIENT'S BEDSIDE. ON (B)(6), THE DOCTOR REMOVED THEIR SHUNT, DEBRIDED THEIR SCALP TISSUE, AND PLACED AN EXTERNAL VENTRICULAR DRAIN (EVD). ON (B)(6) 2017, THE DOCTOR PLACED A NEW SHUNT AT ANOTHER LOCATION ON THE OTHER SIDE OF THE PATIENT'S HEAD.

  Patient problems: Erosion; Wound Dehiscence

  MAUDE report 8634039 ↗
• MalfunctionMar 10, 2017Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THERE WAS A FISSURE ON THE RESERVOIR INTRA-OPERATIVELY. REPORTEDLY, THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6395765 ↗

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