CODMAN® HAKIM® 823842 (REF 82-3842)Recalls & reported problems
Integra Lifesciences Production Corporation · Programmable Valve In-line Valve with SIPHONGUARD™ Device and Unitized Distal Catheter · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780535065), received between Aug 27, 2024 and Aug 27, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Obstruction of Flow” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Obstruction of Flow1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2024Obstruction of Flow; Obstruction of Flow
A PHYSICIAN REPORTED A HAKIM VALVE (ID 823162) WAS IMPLANTED DUE TO SECONDARY NORMAL PRESSURE HYDROCEPHALUS (SNPH) VIA VENTRICULOPERITONEAL (VP) SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. THE DISTAL PART OF THE VALVE HAD RUPTURED HOWEVER, IT WAS NOT PUNCTURED. THEREFORE, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2024 DUE TO SUSPICION OF OBSTRUCTION.
Patient problems: Insufficient Information
MAUDE report 20081300 ↗
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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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