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CODMAN VPV 823192RRecalls & reported problems

Cerenovus, Inc. · CODMAN VPV System Contents: One Each: CODMAN VPV Program Unit, CODMAN VPV Transmitter Unit, Power Cord, Ultrasound Gel, Instructions for Use, and Carrying Case · Class 2

Adverse event reports
6
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886704078609), received between Apr 21, 2022 and Dec 22, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Audible Prompt/Feedback Problem” (2 reports).

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 2 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Audible Prompt/Feedback Problem2
  • Device Emits Odor1
  • Electrical /Electronic Property Problem1
  • Failure to Shut Off1
  • Non Reproducible Results1
  • Overheating of Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions6

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 22, 2024Device Emits Odor; Failure to Shut Off; Device Emits Odor; Failure to Shut Off

    IT WAS REPORTED BY THE FACILITY'S OUTPATIENT DEPARTMENT THAT THE CODMAN VPV PROGRAMMER REVISED (823192R) "DID NOT TURN OFF THEN CRACKLED AND SMELT OF ELECTRICAL BURNING." IT IS UNKNOWN UNDER WHAT CIRCUMSTANCE THIS EVENT OCCURRED; HOWEVER, NO INJURY, DEATH OR SURGICAL DELAY HAS BEEN REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20997797 ↗
  • MalfunctionApr 4, 2024Non Reproducible Results; Non Reproducible Results

    A FACILITY REPORTED A "SHUNT RESET TO 140 RATHER THAN 80 AS REQUESTED, BUT NO ERROR MESSAGE ON SCREEN". DUE TO THIS ISSUE, IT WAS REQUIRED TO TAKE THE PATIENT FOR MULTIPLE X-RAYS. THE EVENT LED TO MORE THAN 30 MINUTES DELAY IN PATIENT CARE, HOWEVER, THE CASE HAPPENED WHEN TRYING TO CHANGE THE PRESSURE SETTINGS IN THE CLINIC. THE PATIENTS HAVE THEN HAD TO GO TO X-RAY TO CHECK AND THEN PRESSURE ADJUSTED AND REPEAT THE PROCESS FOR X-RAY CHECK.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19040975 ↗
  • MalfunctionFeb 1, 2024Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

    1 OF 4 REPORTS. OTHER MFG REPORT NUMBERS: 3013886523-2024-00021, 3013886523-2024-00022, 3013886523-2024-00023. A FACILITY REPORTED: "WE ARE FINDING THAT MOST TIMES WHEN WE TRY TO PROGRAM A VALVE, THE MACHINE WILL TELL US ADJUSTMENT INCOMPLETE MULTIPLE TIMES. HOWEVER, WHEN WE HAVE SENT PATIENTS FOR XR TO CHECK THE STATUS ANYWAY, ON NUMEROUS OCCASIONS WE HAVE FOUND THAT THE VALVE HAS ACTUALLY ADJUSTED - BUT THE MACHINE SAID IT HADN'T." "MULTIPLE PATIENTS HAVE HAD TO ATTEND FOR X-RAYS ON 3-6 OCCASIONS.¿

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18624168 ↗
  • MalfunctionFeb 1, 2024Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

    2 OF 4 REPORTS. OTHER MFG REPORT NUMBERS: 3013886523-2024-00020, 3013886523-2024-00022, 3013886523-2024-00023. A FACILITY REPORTED: "WE ARE FINDING THAT MOST TIMES WHEN WE TRY TO PROGRAM A VALVE, THE MACHINE WILL TELL US ADJUSTMENT INCOMPLETE MULTIPLE TIMES. HOWEVER, WHEN WE HAVE SENT PATIENTS FOR XR TO CHECK THE STATUS ANYWAY, ON NUMEROUS OCCASIONS WE HAVE FOUND THAT THE VALVE HAS ACTUALLY ADJUSTED - BUT THE MACHINE SAID IT HADN'T." "MULTIPLE PATIENTS HAVE HAD TO ATTEND FOR X-RAYS ON 3-6 OCCASIONS.¿

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18624164 ↗
  • MalfunctionAug 17, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

    A FACILITY REPORTED: WHEN THE SURGEON TRIED TO PROGRAM THE VALVE, PROGRAMMER BEGAN TO MAKE SMOG FROM BEHIND. SMELL OF SMOG COMING FROM THE MACHINE. IT WAS IMPOSSIBLE TO KNOW IF THE VALVE WAS PROPERLY REGULATED; THEREFORE, PATIENT HAD A X-RAY EXAM TO CHECK THE PROPER LEVEL OF VALVE REGULATION. PRODUCT WAS IN CONTACT WITH THE PATIENT; HOWEVER, NO PATIENT INJURY REPORTED AND THE EVENT DID NOT LED TO SURGICAL DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15244099 ↗
  • MalfunctionApr 21, 2022Overheating of Device; Overheating of Device

    A FACILITY REPORTED A CODMAN VPV PROGRAMMER WAS OVERHEATING WHEN ATTEMPTING READING FOR PATIENT¿S HAKIM VALVE. NO ADDITIONAL INFORMATION AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14167038 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.