NA 43103 (UDI 00613994800688)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994800688), received between Sep 9, 2020 and Sep 5, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Complete Blockage” (1 report).

1 other recall cover devices cleared under the same FDA submission (K792005); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2023Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A STRATA VALVE AS PART OF THEIR HYDROCEPHALUS TREATMENT. UNFORTUNATELY, THE STRATA VALVE DID NOT FUNCTION AS EXPECTED, WITH INDICATIONS OF POSSIBLE OBSTRUCTION. THE PATIENT EXPERIENCED COMPLICATIONS, WHICH NECESSITATED IMMEDIATE MEDICAL INTERVENTION AND THE DOCTOR DECIDED TO REVISE THE ENTIRE SHUNT IN ORDER TO ADDRESS THE ISSUE EFFECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17683235 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT A VALVE WAS RECENTLY IMPLANTED IN A PATIENT WITH HYDROCEPHALUS. THE INITIAL OUTCOME WAS PROMISING, AS THE PATIENT EXPERIENCED A RESOLUTION OF HYDROCEPHALUS SYMPTOMS AND OVERALL IMPROVEMENT IN HER WELL-BEING. HOWEVER, AFTER A CERTAIN PERIOD, AN EDEMA WAS OBSERVED AROUND THE VENTRICULAR CATHETER. DUE TO THIS CONCERNING DEVELOPMENT, FURTHER INVESTIGATIONS WERE CONDUCTED, INCLUDING ANALYSES TO CHECK FOR SIGNS OF INFECTION. SURPRISINGLY, NO EVIDENCE OF INFECTION WAS FOUND, RULING OUT AN INFECTIOUS ETIOLOGY. NONETHELESS, THE PATIENT BEGAN TO EXPERIENCE ABDOMINAL PAIN, PROMPTING A REPEAT MRI EXAMINATION. THE RESULTS REVEALED THE PRESENCE OF EDEMA ALONG THE PERITONEAL CATHETER, INDICATING A POTENTIAL COMPLICATION RELATED TO THE VALVE OR CATHETER SYSTEM .IN LIGHT OF THE PATIENT'S DETERIORATING CONDITION, THE DOCTOR MADE THE DECISION TO REMOVE BOTH THE VALVE AND CATHETERS. REMARKABLY, THE EDEMA DISAPPEARED FOLLOWING THE REMOVAL OF THE IMPLANT, PROVIDING RELIEF TO THE PATIENT. THE DOCTOR IS CURRENTLY CONDUCTING A COMPREHENSIVE EVALUATION OF THE PATIENT AND WILLSOON PROVIDE US WITH A DETAILED REPORT REGARDING HIS FINDING

  Patient problems: Fever; Inflammation; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 17259737 ↗
• InjuryJan 10, 2022Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT BEING USED IN A HYDROCEPHALUS PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE A CEREBROSPINAL FLUID SHUNT SURGERY, BUT THE ISSUE COULD NOT BE SOLVED AND THE PATIENT END UP IN A COMA. THE PROCEDURE WAS FOR A NORMAL CEREBROSPINAL FLUID SHUNT. IT WAS DETERMINED THAT THERE WAS A BLOCKAGE IN THE SHUNT PASSAGE. THE WHOLE SET OF SHUNT COULD NOT SOLVE THE PROBLEM OF CEREBROSPINAL FLUID DRAINAGE.

  Patient problems: Hydrocephalus

  MAUDE report 13208842 ↗
• InjuryJan 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO NORMAL PRESSURE HYDROCEPHALUS. ON (B)(6) 2020, THEY UNDERWENT VENTRICULAR-ABDOMINAL SHUNT SURGERY UNDER GENERAL ANESTHESIA. DURING THE OPERATION, THE VENTRICULAR-ABDOMINAL SHUNT WAS USED FOR DRAINAGE, AND THE PATIENT'S CONSCIOUSNESS IMPROVED AFTER THE OPERATION. ON (B)(6) 2021, IT WAS DISCOVERED THAT THE PATIENT'S CONSCIOUSNESS DISORDER WAS DEEPER THAN BEFORE. ON (B)(6) 2021, THE VENTRICULAR-ABDOMINAL SHUNT WAS REPLACED UNDER GENERAL ANESTHESIA. DURING THE OPERATION, THE VALVE WAS FOUND TO BE YELLOW AND BLOCKED. IT WAS NOTED THAT IT WAS CONSIDERED THE INCREASE IN CEREBROSPINAL FLUID PROTEIN OR THE PRESENCE OF RED BLOOD CELLS TO BE THE CAUSE OF THE BLOCKAGE. AFTER THE REPLACEMENT, THE PATIENT'S STATE OF CONSCIOUSNESS HAD IMPROVED.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 11243690 ↗
• InjurySep 9, 2020Disconnection; Fracture; Disconnection; Fracture

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S UNDERLYING DISEASE STATE WAS HYDROCEPHALUS, AND THE PATIENT'S CURRENT STATUS WAS BLINDNESS.

  Patient problems: Loss of Vision

  MAUDE report 10508163 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K792005. One submission often covers many models, so check the product and lot details in each record.

• 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