CODMAN HAKIM 82-3190Recalls & reported problems
Cerenovus, Inc. · CODMAN HAKIM Valve Programmer, 100-240V · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 10886704041597), received between Jan 29, 2021 and Sep 12, 2023 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (4 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.
Most reported problems
Device problems
- Overheating of Device4
- Excessive Heating2
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2023Excessive Heating; Excessive Heating
MalfunctionFeb 9, 2023Excessive Heating; Excessive Heating
2 OF 2 REPORTS (SAME PROCEDURE, DIFFERENT PRODUCTS). OTHER MFG REPORT NUMBER: 3013886523-2022-00417. A FACILITY REPORTED: "ELECTRO-MAGNET HEAT, WHICH FORCE THE DOCTOR TO WAIT TIME BETWEEN EACH ATTEMPT TO PROGRAMMED THE VALVE. HE HAS TO SEARCH FOR ICE TO COOL THE DEVICE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16334469 ↗MalfunctionOct 5, 2022Overheating of Device; Overheating of Device
A FACILITY REPORTED A HAKIM PROGRAMMER WAS OVERHEATING. MEDICAL STAFF HAD TO TURN IT OFF, WAIT FOR THE TEMPERATURE TO DROP BEFORE USING IT AGAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15543301 ↗MalfunctionMay 13, 2022Overheating of Device; Overheating of Device
A FACILITY REPORTED A HAKIM PROGRAMMER (ID 823190) WAS OVERHEATING. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14399903 ↗MalfunctionMar 17, 2021Overheating of Device; Overheating of Device
A FACILITY REPORTED THE HAKIM PROGRAMMER OVERHEATS AND THE VALUE COULD NOT BE ADJUSTED. THE ISSUE WAS DETECTED PRE-OPERATIVELY AND NO SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11510110 ↗MalfunctionJan 29, 2021Overheating of Device; Output Problem; Overheating of Device; Output Problem
A FACILITY REPORTED THE HAKIM PROGRAMMER STOPPED WORKING, OVERHEATED AND WOULD NOT ALLOW SETTING TO BE SELECTED. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 11254847 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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