CODMAN HOLTER RICKHAM 82-1617Recalls & reported problems
Cerenovus, Inc. · CODMAN HOLTER SALMON-RICKHAM Reservoir With Nylon Base for 6mm Burr Hole · Class 2 · Implant
Data updated Oct 18, 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 10886704040477), received between Mar 23, 2022 and Mar 23, 2022 — classified as 2 injuries.
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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Bacterial Infection1
- Fatigue1
- Fever1
- Swelling/ Edema1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 23, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
STUDY; PATIENT RECEIVES INTRAVENTRICULAR ENZYME THERAPY EVERY 14 DAYS VIA RICKHAM RESERVOIR. AFTER THE INTRAVENTRUICULAR THERAPY ON (B)(6) 2021, PATIENT PRESENTED WITH FEVER AND INCREASING TIREDNESS ON (B)(6) 2021. IN A SAMPLE FROM (B)(6) 2021 BEFORE INTRAVENTRICULAR THERAPY, STAPH CAPITIS WAS DETECTED; THEREFORE, RICKHAM RESERVOIR WAS EXPLANTED ON (B)(6) 2021 FOLLOWING ANTIBIOTIC THERAPY FOR 14 DAYS AND REPLACEMENT OF THE RICKHAM RESERVOIR ON (B)(6) 2021. PATIENT RECOVERED.
Patient problems: Bacterial Infection; Fatigue; Fever
MAUDE report 13862050 ↗InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
STUDY: TO TREAT PATIENT'S UNDERLYING DISEASE (CLN2-LATE INFANTILE NEURONAL CEROID LIPOFUSCINOSIS TYPE 2), THE PATIENT RECEIVED INTRAVENTRICULAR ENZYME THERAPY EVERY 14 DAYS VIA AN IMPLANTED RICKHAM RESERVOIR (821617). THE RESERVOIR WAS IMPLANTED ON (B)(6) 2020. ON (B)(6) 2021, THERE WERE REPEATED SWELLINGS IN THE FACE AND WET BANDAGES AFTER THE ENZYME THERAPY, THEREFORE, THE RESERVOIR WAS REPLACED ON (B)(6) 2021. PATIENT LEFT THE CLINIC ON (B)(6) 2021 WITHOUT ANY ISSUE.
Patient problems: Swelling/ Edema
MAUDE report 13860796 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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