CODMAN® HAKIM® 823116Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® HAKIM® Programmable Valve Micro Valve with RICKHAM® Reservoir Programmable in steps of 10mm H2O (98 Pa): 30mm H2O to 200mm H2O (294 Pa - 1960 Pa) · Class 2 · Implant
All models of CODMAN HAKIM (36)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780519195), received between Mar 29, 2022 and Mar 20, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Align” (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
- Failure to Align1
- Fluid/Blood Leak1
- Loose or Intermittent Connection1
Patient problems
- Cerebrospinal Fluid Leakage1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 20, 2026Failure to Align
A FACILITY REPORTED A HAKIM VALVE (ID 823116) WAS IMPLANTED ON (B)(6) 2026, DUE TO HYDROCEPHALUS. THE VALVE ADJUSTMENT FAILED AND THE PHYSICIAN MADE A MULTIPLE ATTEMPT MORE THAN 2-3 TIMES TO ADJUST WITHOUT SUCCESS. TWO DIFFERENT ADJUSTMENT TOOLS WERE USED, BUT NEITHER WORKED. IT WAS CONFIRMED THAT THE UNIT WAS DEFECTIVE.
Patient problems: Insufficient Information
MAUDE report 24647786 ↗MalfunctionNov 17, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
A FACILITY REPORTED THE CONNECTION PART OF A HAKIM VALVE RESERVOIR IS LIKELY TO FALL OUT. THE RESERVOIR IS UNEVEN, THEREFORE, IT WAS REPLACED WITH A NEW PRODUCT. THE EVENT LED TO 30 MINUTES SURGICAL DELAY. THE ISSUE WAS CONFIRMED DURING THE IMPLANTATION PROCEDURE, BEFORE IMPLANTATION SITE CLOSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18160755 ↗InjuryMar 29, 2022Fluid/Blood Leak; Fluid/Blood Leak
A PHYSICIAN REPORTED A HAKIM VALVE WAS IMPLANTED ON (B)(6) 2022. A CSF LEAK WAS NOTED AND ON (B)(6) 2022, A REVISION SURGERY WAS DONE AND FOUND THE VALVE HAD CLEAR BACKFLOW THROUGH THE RICKHAM SYSTEM WITH BLOOD COMING BACK FROM THE HEART. THE VALVE WAS EXPLANTED AND REPLACED ON (B)(6) 2022.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 13938516 ↗
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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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