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CODMAN 82-1705Recalls & reported problems

Cerenovus, Inc. · CODMAN External Drainage Ventricular Catheter Set · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704040798), received between Jan 16, 2018 and Jan 16, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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

  • Leak/Splash1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJan 16, 2018Leak/Splash; Leak/Splash

    AS REPORTED 23 OCT 2017 BY CODMAN TO NATUS: "AS REPORTED BY THE OUS AFFILIATE, A CODMAN EXTERNAL DRAINAGE CATHETER SET LEAKED AT THE CATHETER CONNECTIONS. NO REPORT OF PERMANENT CONSEQUENCES TO THE PATIENT." ADDITIONAL INFORMATION TAKEN FROM "COMPLAINTS (B)(4)" COMPLAINT RECORD RECEIVED FROM CODMAN BY NATUS ON 15 JAN 2018: "WAS THERE SURGICAL DELAY REPORTED? NO" "IS THIS A REVISION OF ONE OR MORE IMPLANTS? NO" DEVICE INDICATED AS AVAILABLE FOR RETURN. DEVICE RECEIVED AT DECONTAMINATION LABORATORY IN (B)(6) ON 17 NOV 2017.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7198052 ↗

Other Shunt, central nervous system and components devices

All Shunt, central nervous system and components devices →

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