CODMAN HAKIM 82-3111Recalls & reported problems
Cerenovus, Inc. · CODMAN HAKIM Programmable Valve Cylindrical Valve with Prechamber 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, Straight Connector, Introducer and Right Angle 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 10886704041467), received between Apr 5, 2022 and Oct 31, 2024 — classified as 5 injuries.
The most frequently reported specific device problem is “Infusion or Flow Problem” (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
- Infusion or Flow Problem2
- Adverse Event Without Identified Device or Use Problem1
- Obstruction of Flow1
- Positioning Failure1
Patient problems
- Insufficient Information3
- Ambulation or Postural Difficulties1
- Confusion/ Disorientation1
- Meningitis1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryOct 31, 2024Positioning Failure; Positioning Failure
InjuryAug 2, 2024Infusion or Flow Problem; Infusion or Flow Problem
A PHYSICIAN REPORTED A HAKIM VALVE (UNKNOWN ID) CEASED TO DRAIN. THEREFORE, THE PHYSICIAN IMPLANTED A NEW VALVE FROM A DIFFERENT BRAND. THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER SEVERAL ATTEMPTS.
Patient problems: Insufficient Information
MAUDE report 19893076 ↗InjuryJun 21, 2024Infusion or Flow Problem; Infusion or Flow Problem
N/A.
Patient problems: Ambulation or Postural Difficulties; Confusion/ Disorientation
MAUDE report 19590355 ↗InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 5, 2022Obstruction of Flow; Obstruction of Flow
A PHYSICIAN REPORTED A HAKIM VALVE (ID 823111) WAS IMPLANTED VIA V-P SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING, THE PATIENT DEVELOPED MENINGITIS AND SHUNT OBSTRUCTION WAS SUSPECTED. THE VALVE WAS REMOVED ON (B)(6) 2022. IT WAS UNKNOWN IF THE VALVE WAS REPLACED. THE PATIENT CURRENT CONDITION IS UNKNOWN.
Patient problems: Meningitis
MAUDE report 14015392 ↗
Other Shunt, central nervous system and components devices
- NATUS EDS3 DRAINAGE SYSTEM NT821731CNatus Medical Incorporated · Shunt, Central Nervous System And Components1 recall208 reports
- Exacta™ 46700Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall2 deaths163 reports
- Strata® 42866Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 death160 reports
- proGAV 2.0® FX410TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components119 reports
- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.