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CODMAN HAKIM 82-3807Recalls & reported problems

Cerenovus, Inc. · CODMAN HAKIM Precision Fixed Pressure Valve In-Line Valve and Unitized Distal Catheter Operating Pressure: 40mm H2O Plus or Minus 10mm H2O (392 Pa Plus or Minus 98 Pa) Low Range Includes: Precision Valve, 14cm Ventricular Catheter, 120cm Unitized Peritoneal Catheter, Information Manual, Right Angle Adapter and Priming Adapter · Class 2 · Implant

All models of CODMAN HAKIM (17)

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 10886704041733), received between Jul 28, 2022 and Sep 1, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Device problems

  • Break1
  • Migration or Expulsion of Device1

Patient problems

  • Hydrocephalus1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjurySep 1, 2022Break; Break

    A FACILITY REPORTED A HAKIM VALVE (ID 823807) WAS IMPLANTED ON (B)(6) 2022. THE UNITIZED SHUNT IS BROKEN AT THE POINT WHERE DISTAL CATHETER IS CONNECTED TO THE VALVE. IT WAS CLEARLY SEEN ON THE X-RAY THAT THE DISTAL CATHETER WAS NO LONGER CONNECTED TO THE VALVE. THE PATIENT BEGAN TO EXHIBIT CLINICAL SIGNS OF HYDROCEPHALUS ON (B)(6) 2022 AND A RADIOGRAPH WAS PERFORMED WHICH SHOWED THE SHUNT DEFECT. INFORMATION RECEIVED ON (B)(6) 2022 INDICATES THE CARE PLAN IS TO SEE IF THE PATIENT CAN BE MEDICALLY MANAGED BEFORE DECIDING TO DO ANOTHER SURGERY AND REPLACE THE VALVE. IN REGARDS THE CLINICAL SIGNS, MEDICAL STAFF IS STILL WAITING TO SEE IF MEDICAL MANAGEMENT IS SUFFICIENT.

    Patient problems: Hydrocephalus

    MAUDE report 15337402 ↗
  • InjuryJul 28, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

    2 OF 3 REPORTS. OTHER MFG REPORT NUMBERS: 3013886523-2022-00349, 3013886523-2022-00351. A FACILITY REPORTED 3 CATHETERS WERE IMPLANTED RECENTLY IN 3 DIFFERENT PEDIATRIC PATIENTS. AFTER FEW DAYS THEY HAD THE NEED THE REMOVE THE PERITONEAL CATHETER (NOT RELATED TO VALVE SYSTEM MALFUNCTION) AND THEY WEREN¿T ABLE TO PULL AWAY THE CATHETER (THAT WAS LEFT IN THE PERITONEAL SPACE. THE CATHETER WAS LEFT WITH ITS ENTIRE LENGTH WITHOUT LOOP CONFIGURATION). IN THE MOST SEVERE CASE, THE CATHETER WAS KNOT TOGETHER WITH AN INTESTINAL LOOP AND REQUIRE A SURGERY TO CUT THE LOOP.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15126920 ↗

Other Shunt, central nervous system and components devices

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Sources and updates

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