CODMAN® HOLTER® SALMON™-RICKHAM® 821625Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® HOLTER® SALMON-RICKHAM® CODMAN® HOLTER® SALMON™ RICKHAM® Reservoir With Stainless Steel Base for 6mm Burr Hole · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10381780517795), received between Jan 5, 2023 and Oct 17, 2025 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).
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
- Fluid/Blood Leak3
- Insufficient Device Problem Information1
- Naturally Worn1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Cerebrospinal Fluid Leakage1
- Dyskinesia1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
InjuryNov 26, 2024Fluid/Blood Leak; Fluid/Blood Leak
InjuryApr 10, 2024Fluid/Blood Leak; Fluid/Blood Leak
InjuryOct 9, 2023Naturally Worn; Naturally Worn
InjuryJan 5, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
MEDWATCH (B)(4). STUDY: 12 MONTH-OLD FEMALE PATIENT. THIS CASE WAS REPORTED BY A PHYSICIAN. THE PATIENT'S PAST MEDICAL HISTORY WAS DEVICE MALFUNCTION AND MEDICAL DEVICE ADJUSTMENT. THE PATIENT'S CONCURRENT CONDITIONS WERE NEURONAL CEROID LIPOFUSCINOSIS. NO ALLERGIES WERE REPORTED. NO CONCOMITANT MEDICATIONS WERE REPORTED. ON (B)(6) 2022, THE PATIENT UNDERWENT IMPLANTATION OF INTRACEREBRAL VENTRISCULOSTOMY (ICV) SET (CODMAN RICKHAM; MODEL NUMBER NOT REPORTED). THE LOT NUMBER WAS 6406334. ON (B)(6) 2022, THE PATIENT INITIATED TREATMENT WITH BRINEURA (200 MILLIGRAM, QOW, INTRACEREBROVENTRICULAR USE) FOR THE INDICATION NEURONAL CEROID LIPOFUSCINOSIS. THE LOT NUMBER FOR BRINEURA WAS NOT REPORTED. THE MOST RECENT DOSE WAS ADMINISTERED ON AN UNREPORTED DATE. ON (B)(6) 2022, THERE WAS CONCERN FOR ONGOING CATHETER MISPLACEMENT DESPITE RECENT ICV RESERVOIR REVISION. THE TEAM WAS ASSESSING WHETHER THERE WAS AN ISSUE WITH THE CATHETER VIA IMAGING AND CONSULTATION WITH NEUROSURGERY. AT THE TIME OF THIS REPORT, THE PATIENT WAS AWAITING NEUROIMAGING UNDER SEDATION. ON (B)(6) 2022, THERE WERE TWO UNSUCCESSFUL ATTEMPTS TO ACCESS THE ICV RESERVOIR, WITH SCANT BLOOD RETURN EACH TIME (CSF RED BLOOD CE
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16104473 ↗
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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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