CODMAN® HAKIM® 823113 (REF 82-3113)Recalls & reported problems
Integra Lifesciences Production Corporation · Programmable Valve Micro Valve with RICKHAM® reservoir and Unitized Distal Catheter · Class 2 · Implant
All models of CODMAN HAKIM (36)
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 10381780534501), received between Jul 3, 2024 and Oct 2, 2025 — classified as 2 injuries.
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
- Material Rupture1
Patient problems
- Cerebral Edema1
- Sleepiness/Drowsiness/Somnolence1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 2, 2025Failure to Align; Failure to Align
InjuryJul 3, 2024Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture
A PHYSICIAN REPORTED AN 18-DAY MALE CHILD PATIENT WHO EXPERIENCED CSF LEAKAGE, SHUNT MALFUNCTION AND CATHETER RUPTURE DURING THE USE OF CHPV SHUNT (BACTISEAL CATHETER KIT ID 823072) FOR UNKNOWN INDICATION. NOT REPORTED: PATIENT MEDICAL HISTORY, CONCURRENT CONDITION, FAMILY HISTORY, PAST MEDICATION, CONCOMITANT AND CO-SUSPECT MEDICATIONS, DRUG ALLERGIES. ON (B)(6) 2024, A CHPV SHUNT (ID 823072) WAS IMPLANTED AT AN UNKNOWN FREQUENCY VIA AN UNKNOWN ROUTE. ON (B)(6) 2024, THE PATIENT WAS ADMITTED WITH THE COMPLAINT OF FLUID ACCUMULATION UNDER THE NECK REGION. SURGEON HAS BEEN SUSPICIOUS ABOUT THE CEREBROSPINAL FLUID LEAKAGE (CSF) LEAKAGE FROM THE SHUNT-CATHETER JUNCTION (SHUNT MALFUNCTION) AND BACTISEAL CATHETER RUPTURE AFTER IMPLANTATION (DEVICE BREAKAGE). AT THE TIME OF THE REPORTING, THE OUTCOME OF THE EVENTS CSF LEAKAGE, SHUNT MALFUNCTION, DEVICE BREAKAGE WAS UNKNOWN. PERTINENT LAB DATA INCLUDED: ON AN UNKNOWN DATE, X-RAY SHOWS MALFUNCTION. THE ACTION TAKEN WITH CHPV SHUNT (ID 823072) WAS UNKNOWN. REACTION DESCRIPTION AS PER REPORTER: CAUSALITY FOR THE EVENTS CSF LEAKAGE, SHUNT MALFUNCTION, DEVICE BREAKAGE WAS NOT REPORTED FOR CHPV SHUNT (ID 823072). THE CASE SERIOUSNESS WAS REPORT
Patient problems: Cerebral Edema
MAUDE report 19667923 ↗
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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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