CODMAN HAKIM 82-3834Recalls & reported problems
Cerenovus, Inc. · CODMAN HAKIM Programmable Valve In-Line Valve 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
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886704041832), received between Sep 23, 2021 and Jun 24, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (2 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.
Reports received per month
Most reported problems
Device problems
- Device Difficult to Program or Calibrate2
- Obstruction of Flow2
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information3
- Failure of Implant1
- Hydrocephalus1
- Nausea1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJun 24, 2025Obstruction of Flow; Insufficient Device Problem Information; Obstruction of Flow; Insufficient Device Problem Information
InjuryDec 11, 2023Obstruction of Flow; Obstruction of Flow
InjuryApr 12, 2023Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
A FACILITY REPORTED THAT MEDICAL STAFF WERE UNABLE TO REPROGRAM A HAKIM VALVE (ID 823834) AFTER MRI. THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2023. THE VALVE WAS IMPLANTED IN A 2 YEAR-OLD FEMALE PATIENT TO TREAT HYDROCEPHALUS.
Patient problems: Insufficient Information
MAUDE report 16725198 ↗InjuryDec 8, 2021Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
A FACILITY REPORTED THE PHYSICIAN WAS NOT ABLE TO REPROGRAM A HAKIM VALVE. THEY ALSO TRIED TO REPROGRAM THE VALVE USING TWO DIFFERENT PROGRAMMERS UNSUCCESSFULLY. VALVE MALFUNCTION WAS SUSPECTED AND IT WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 12964936 ↗InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED A HAKIM VALVE WAS IMPLANTED TO A PATIENT ON (B)(6) 2021. THE PATIENT HAD NAUSEA SYMPTOMS AND MAY REQUIRE THEIR CHPV VALVE TO BE ADJUSTED. THE NAUSEA SYMPTOMS PRESENTED AROUND THE TIME OF PATIENT'S SECONDARY SURGERY ON (B)(6) 2021 FOR A REVISION OF C6-7 FUSION AND THE CLOSURE OF THE DURA FROM A CSF LEAK. THE SHUNT WAS ORIGINALLY SET AT 160MMHG AND ADJUSTED 24 HOURS POST OP TO 120MMHG. THE SHUNT WAS THEN ADJUSTED TO 140MMHG ON (B)(6) 2021. THE PATIENT STILL HAVE NAUSEA SYMPTOMS.
Patient problems: Nausea
MAUDE report 12523971 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.