CODMAN HAKIM 82-3844Recalls & reported problems
Cerenovus, Inc. · CODMAN HAKIM Programmable Valve In-Line Valve and Unitized Distal Catheter Programmable in steps of 10mm H2O (98 Pa): 30mm H2O to 200mm H2O (294 Pa - 1960 Pa) Includes: Programmable Valve, 14cm Ventricular Catheter, 120cm Peritoneal Catheter, Information Manual, Right Angle Adapter and Priming Adapter · Class 2 · Implant
All models of CODMAN HAKIM (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704041863), received between Nov 2, 2022 and Mar 28, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Device Difficult to Program or Calibrate1
- Insufficient Device Problem Information1
Patient problems
- Cerebral Ventriculomegaly1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 28, 2025Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
A FACILITY REPORTED: THE PATIENT HAD AN MRI DONE AND THE SURGEON SEEMS TO THINK IT AFFECTED THE SETTINGS OF THE HAKIM VALVE (ID (B)(6)). WITH NUMEROUS ATTEMPTS THEY HAVE NOT BEEN ABLE TO READJUST THE SETTINGS SINCE, THEREFORE, THE VALVE WAS REMOVED AND REPLACED. THE PATIENT WAS NOT EXPOSED TO SIGNIFICANT ACCELERATION OR DECELERATION SUCH AS A CAR ACCIDENT OR FALL. THE VALVE WAS IMPLANTED ON (B)(6) 2019 AND EXPLANTED ON (B)(6) 2025.
Patient problems: Insufficient Information
MAUDE report 21721033 ↗InjuryNov 2, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
A FACILITY REPORTED A HAKIM VALVE (ID 823844) WAS IMPLANTED VIA V-P SHUNT ON (B)(6) 2019 WITH UNKNOWN SETTING. THE PATIENT HAD VENTRICULAR ENLARGEMENT; THEREFORE, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2022. ACCORDING TO PHYSICIAN, THE CAUSE OF VENTRICULAR ENLARGEMENT IS UNKNOWN, HOWEVER, IT WAS BELIEVED THAT THIS EVENT WAS POSSIBLY HAPPENED BY OBSTRUCTION OR KINK OF CATHETER.
Patient problems: Cerebral Ventriculomegaly
MAUDE report 15717362 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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