CODMAN HOLTER 82-1618Recalls & reported problems
Cerenovus, Inc. · CODMAN HOLTER SELKER Reservoir Standard With Nylon Base for 4mm Burr Hole 14mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10886704040484), received between Apr 29, 2025 and Apr 29, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Material Integrity Problem” (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.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 29, 2025Material Integrity Problem; Material Integrity Problem
AN INVESTIGATOR REPORTED THIS CASE FROM THE BIOMARIN STUDY; CERLIPONASE ALFA OBSERVATIONAL STUDY. 7 YEARS-OLD FEMALE SUBJECT: PAST MEDICAL HISTORY WAS NOT REPORTED. ON AN UNSPECIFIED DATE, THE SUBJECT UNDERWENT IMPLANTATION OF INTRACEREBRAL VENTRICULOSTOMY (ICV) SET (MANUFACTURER, MODEL NUMBER, AND LOT NUMBER NOT REPORTED). ON (B)(6) 2018, THE SUBJECT INITIATED TREATMENT WITH BRINEURA (150 MILLIGRAM, QOW, INTRACEREBROVENTRICULAR). THE LOT NUMBER FOR BRINEURA WAS NOT REPORTED. THE MOST RECENT DOSE WAS ADMINISTERED ON (B)(6) 2020. ON (B)(6) 2022 AT 10:26, THE SUBJECT EXPERIENCED GRADE 1 DEVICE MALFUNCTION (DEVICE MALFUNCTION) AFTER REPEATED TAPPING IN ADDITION TO INJECTIONS WITH BRINEURA THAT CAUSED SOME REACTIVE INFLAMMATION AND OBLITERATED THE DEVICE SYSTEM. NO LABORATORY OR DIAGNOSTIC TESTS WERE REPORTED. NO TREATMENT FOR THE EVENT WAS REPORTED. NO ACTION WAS TAKEN WITH BRINEURA DUE TO THE EVENT. THE OUTCOME OF THE EVENT WAS REPORTED AS RECOVERED/RESOLVED ON (B)(6) 2022. THE INVESTIGATOR ASSESSED THE EVENT OF DEVICE MALFUNCTION AS NOT RELATED TO TREATMENT WITH BRINEURA AND RELATED TO THE ICV DEVICE. NO OTHER ETIOLOGICAL FACTORS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED ON 18-
Patient problems: Insufficient Information
MAUDE report 21930636 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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