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CODMAN HAKIM 82-5473Recalls & reported problems

Cerenovus, Inc. · CODMAN HAKIM Precision Fixed Pressure Valve In-Line Valve Operating Pressure: 70mm H2O Plus or Minus 10mm H2O (686 Pa Plus or Minus 98 Pa) Medium Low Range Includes: Precision Valve, Information Manual and Priming Adapter · Class 2 · Implant

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 10886704042020), received between Jul 14, 2021 and Jul 14, 2021 — 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.

Most reported problems

Device problems

  • Obstruction of Flow1

Patient problems

  • Failure of Implant1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 14, 2021Obstruction of Flow; Obstruction of Flow

    A FACILITY REPORTED A CODMAN HAKIM PRECISION FIXED PRESSURE VALVE IN-LINE VALVE WAS IMPLANTED IN A PATIENT ON (B)(6) 2021. THE FACILITY REPORTED FLUID WAS TRACKING AROUND THE VALVE AND THE DECISION WAS MADE TO TAP THE SHUNT. THE SITE WAS PREPPED AND DRAPED IN STERILE FASHION. A 23-GAUGE BUTTERFLY NEEDLE WAS INSERTED INTO THE RESERVOIR. THERE WAS AN IMMEDIATE RETURN OF CLEAR CEREBRAL SPINAL FLUID, DRIPPING BRISKLY. THE OPENING PRESSURE WAS 6-7CM. WITH PROXIMAL PORTION OCCLUDED THERE WAS SLUGGISH TO NO DISTAL RUNOFF. SUBSEQUENTLY, 25 MILLILITERS OF CEREBRAL SPINAL FLUID WERE WITHDRAWN, AFTER FONTANELLE WAS SOFT, SLIGHTLY CONCAVE. THE PROVIDER THEN ATTEMPTED TO FLUSH DISTALLY. THE PATIENT WAS RE-PREPPED AND DRAPED. A BUTTERFLY NEEDLE WAS INSERTED INTO THE RESERVOIR. THERE WAS AGAIN IMMEDIATE RETURN OF CLEAR CEREBRAL SPINAL FLUID, WITH AN OPENING PRESSURE OF 4-5CM. WITH THE OCCLUDED PROXIMAL CATHETER, 10 MILLILITERS WERE FLUSHED THROUGH THE DISTAL PORTION. WITH PROXIMAL PORTION OCCLUDED, NO DISTAL RUNOFF, FLUID COLUMN ROSE AND BUBBLED OVER THE END OF THE TUBING. PROXIMAL PORTION OCCLUDED; ANOTHER 20 MILLILITERS FLUSHED DISTALLY. AGAIN, NOTED TO HAVE BRISK DRAINAGE WHEN NOTHING OCCLUDED

    Patient problems: Failure of Implant

    MAUDE report 12170783 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.