CODMAN HOLTER RICKHAM 82-1623Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886704040514), received between Sep 23, 2022 and Feb 20, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2026Fluid/Blood Leak

  STUDY - THIS CASE REFERS TO AN APPROXIMATELY 11-OLD MALE PARTICIPANT. AN INVESTIGATOR REPORTED THIS CASE FROM THE BIOMARIN SPONSORED STUDY, CERLIPONASE ALFA OBSERVATIONAL STUDY. "ON 12-SEP-2019, THE PARTICIPANT UNDERWENT IMPLANTATION OF INTRACEREBRAL VENTRICULOSTOMY (ICV) SET (RICKHAM, CODMAN). THE CATALOG AND MODEL NUMBER WERE 82-1623. THE LOT NUMBER WAS 3693875 AND THE SERIAL NUMBER WAS UNKNOWN." "ON 12-SEP-2019, THE PARTICIPANT WAS INITIATED ON TREATMENT WITH BRINEURA (300 MILLIGRAM, QOW, INTRACEREBROVENTRICULAR USE). THE LOT NUMBER FOR BRINEURA WAS NOT REPORTED. THE MOST RECENT DOSE WAS ADMINISTERED ON 20-JAN-2026." "ON 20-JAN-2026, THE PARTICIPANT'S BRINEURA INFUSION WAS ADMINISTERED FROM 08:30 TO 13:00. AT 14:30, THE PARTICIPANT DEVELOPED A GRADE 3 INTRAVENTRICULAR RESERVOIR LEAK. THERE WAS LEAKING SEEN FROM THE INFUSION SITE. THE PARTICIPANT WAS SUBSEQUENTLY HOSPITALIZED DUE TO THE EVENT. ON 21-JAN-2026, THE DEVICE WAS SUCCESSFULLY REPLACED WITH A POWER PORT SLIM IMPLANTABLE PORT, 6F SINGLE LUMEN. THE EVENT OCCURRED AT THE CLINIC, AND THE DEVICE IS NOT AVAILABLE FOR RETURN. NO LABORATORY OR DIAGNOSTIC TESTS WERE REPORTED. NO TREATMENT FOR THE EVENT WAS REPORTED. NO ACTION WA

  Patient problems: Insufficient Information

  MAUDE report 24400468 ↗
• InjuryFeb 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  2 OF 2 REPORTS. OTHER MFG REPORT NUMBERS: 3013886523-2024-00048. A PATIENT REPORTED "PAIN AND SUFFERING". NO ADDITIONAL INFORMATION WAS PROVIDED AFTER SEVERAL ATTEMPTS.

  Patient problems: Pain

  MAUDE report 18743357 ↗
• InjuryFeb 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  STUDY - THE CASE IS A REPORT REFERRING TO AN APPROXIMATELY 10 YEARS-OLD MALE SUBJECT. AN INVESTIGATOR REPORTED THIS CASE FROM THE BIOMARIN SPONSORED STUDY, CERLIPONASE ALFA OBSERVATIONAL STUDY. "ON AN UNREPORTED DATE, THE SUBJECT UNDERWENT IMPLANTATION OF INTRACEREBRAL VENTRICULOSTOMY (ICV) SET (CODMAN [GENERIC] NUMBER UNREPORTED; MODEL UNREPORTED) LOT NUMBER UNREPORTED. " "ON (B)(6) 2018, THE SUBJECT INITIATED TREATMENT WITH BMN 190 (300 MILLIGRAM, QOW, ICV). THE LOT NUMBER FOR BMN 190 WAS 4304722. THE MOST RECENT DOSE WAS ADMINISTERED ON (B)(6) 2022." "ON AN UNREPORTED DATE, REPORTED AS TWO WEEKS AGO, A CEREBRAL SPINAL FLUID CULTURE (CSF) WAS TAKEN WHEN IVD WAS ASSESSED; RESULTS WERE PENDING. ON (B)(6) 2022 AT 15:24, THE RESULTS OF THE CSF CULTURE TAKEN TWO WEEKS AGO WAS POSITIVE (CSF CULTURE POSITIVE) FOR PROPIONIBACTERIUM ACNES. HE WAS AT HIS NEUROLOGIC BASELINE AND DID NOT HAVE ANY FEVERS OR SIGNS OF CNS INFECTION. ON THE SAME DAY, THE SUBJECT WAS HOSPITALIZED. THE SEVERITY OF THE EVENT WAS REPORTED AS GRADE 3. INFECTION DISEASE AND NEUROSURGERY WAS CONSULTED AND HE WAS RECOMMENDED FOR A TRANSFER TO INPATIENT MEDICINE. TREATMENT FOR THE EVENT INCLUDED UNSPECIFIED INTRAVENOUS A

  Patient problems: Bacterial Infection

  MAUDE report 16454418 ↗
• InjurySep 23, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  STUDY - "THIS CASE IS A REPORT REFERRING TO AN APPROXIMATELY 10 YEAR-OLD MALE SUBJECT. AN INVESTIGATOR REPORTED THIS CASE FROM THE BIOMARIN SPONSORED STUDY, CERLIPONASE ALFA OBSERVATIONAL STUDY." "ON AN UNSPECIFIED DATE, THE SUBJECT UNDERWENT IMPLANTATION OF A MEDTRONICS INTRACEREBROVENTRICULAR DEVICE (ICV)" "ON (B)(6) 2018, THE SUBJECT INITIATED TREATMENT WITH BRINEURA (300 MILLIGRAM, QOW, INTRACEREBROVENTRICULAR). THE MOST RECENT DOSE WAS ADMINISTERED ON (B)(6) 2022 FROM 08:26 TO 14:50." "ON (B)(6) 2022 AT 17:54, THE SUBJECT EXPERIENCED GRADE 3 DEVICE RELATED INFECTION (DEVICE RELATED INFECTION) AND WAS HOSPITALIZED THAT DAY DUE TO THE EVENT. ON THAT SAME DAY, PER ID RECOMMENDATIONS, THE PATIENT WAS STARTED ON A 14-DAY COURSE OF CEFTRIAXONE SODIUM AS TREATMENT FOR THE EVENT FOR GRAM POSITIVE RODS, PRESUMED C. ACNES. ON (B)(6) 2022, THE PATIENT UNDERWENT REMOVAL OF THE OMMAYA RESERVOIR AND HAD A PICC PLACEMENT IN THE OPERATING ROOM. THE PATIENT WAS DISCHARGED ON UNSPECIFIED ANTIBIOTICS AS TREATMENT FOR THE EVENT WITH A PLAN FOR 14-DAY COURSE OF TREATMENT. TREATMENT ADDITIONALLY INCLUDED LEAVING THE OMMAYA RESERVOIR OUT FOR 4 WEEKS WITH REPLACEMENT PRIOR TO THE PATIENT'S NEXT SCHED

  Patient problems: Bacterial Infection

  MAUDE report 15472783 ↗