CODMAN® HOLTER® RICKHAM® 821616Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10381780517733), received between May 31, 2023 and Apr 11, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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.

• InjuryApr 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  STUDY: CASE DESCRIPTION: THIS CASE IS REFERRING TO AN APPROXIMATELY 7 YEAR-OLD MALE PARTICIPANT. AN INVESTIGATOR REPORTED THIS CASE FROM THE BIOMARIN STUDY, CERLIPONASE ALFA OBSERVATIONAL STUDY." THE PARTICIPANT'S PAST MEDICAL HISTORY WAS NOT REPORTED. THE PARTICIPANT'S CONCURRENT CONDITIONS INCLUDED EPILEPSY, GASTROOESOPHAGEAL REFLUX DISEASE, VOMITING, BEHAVIOUR DISORDER, NEURONAL CEROID LIPOFUSCINOSIS AND SLEEP DISORDER. NO ALLERGIES WERE REPORTED." "ON AN UNREPORTED DATE, THE PARTICIPANT UNDERWENT IMPLANTATION OF INTRACEREBRAL VENTRICULOSTOMY (ICV) SET (MANUFACTURER UNKNOWN). THE LOT NUMBER WAS NOT REPORTED." "ON (B)(6) 2024, THE PARTICIPANT INITIATED TREATMENT WITH BRINEURA (300 MILLIGRAM, QOW, INTRACEREBROVENTRICULAR). THE LOT NUMBER FOR BRINEURA WAS NOT REPORTED. THE MOST RECENT DOSE OF BRINEURA WAS ADMINISTERED ON (B)(6) 2024." ON (B)(6) 2024 THE PARTICIPANT RECEIVED THEIR BRINEURA INFUSION AND THERE WAS NO PLEOCYTOSIS PRESENT AT THAT TIME AND A CEREBROSPINAL FLUID (CSF) CULTURE BECAME POSITIVE FOR GRAM POSITIVE COCCI IN CLUSTERS. ON (B)(6) 2024 AT 13:15, THE PARTICIPANT EXPERIENCED GRADE 3 DEVICE RELATED INFECTION (DEVICE RELATED INFECTION). ON THE SAME DATE, THE PARTICIPAN

  Patient problems: Bacterial Infection

  MAUDE report 19091174 ↗
• InjuryFeb 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  N/A

  Patient problems: Unspecified Infection

  MAUDE report 18662582 ↗
• InjuryJun 22, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  STUDY: THIS CASE REFERS TO AN APPROXIMATELY 8 YEAR-OLD FEMALE SUBJECT. AN INVESTIGATOR REPORTED THIS CASE FROM THE BIOMARIN SPONSORED 190-504 STUDY, CERLIPONASE ALFA OBSERVATIONAL STUDY. THE SUBJECT'S PAST MEDICAL HISTORY AND PROCEDURES INCLUDED: DEVELOPMENTAL HIP DYSPLASIA, RASH MACULO-PAPULAR, INFUSION RELATED REACTION, COVID-19, GASTROSTOMY, DEVICE RELATED INFECTION, AND MEDICAL DEVICE ADJUSTMENT. THE SUBJECT'S CONCURRENT CONDITIONS INCLUDED: SLEEP DISORDER, HYPERTONIA, DYSTONIA, EPILEPSY, AND NEURONAL CEROID LIPOFUSCINOSIS. NO ALLERGIES WERE REPORTED. CONCOMITANT MEDICATION INCLUDED: LEVETIRACETAM, TRIHEXYPHENIDYL, MIDAZOLAM, CLOBAZAM, BACLOFEN, HYDROXYZINE, MELATONINE, PREGABALIN, AND PIPAMPERONE. PREMEDICATION INCLUDED: CLEMASTINE, DEXAMETHASONE, AND PARACETAMOL. ON AN UNSPECIFIED DATE, THE SUBJECT UNDERWENT IMPLANTATION OF AN INTRACEREBROVENTRICULAR (ICV) DEVICE. THE DEVICE MANUFACTURER, DEVICE NUMBER, LOT NUMBER, AND MODEL NUMBER WERE NOT REPORTED. ON (B)(6)2018, THE SUBJECT INITIATED TREATMENT WITH BRINEURA (300 MILLIGRAM, QOW, INTRACEREBROVENTRICULAR USE). THE LOT NUMBER FOR BRINEURA WAS NOT REPORTED. THE MOST RECENT DOSE WAS ADMINISTERED ON (B)(6) 2023. ON (B)(6) 2023, T

  Patient problems: Unspecified Infection

  MAUDE report 17182406 ↗
• InjuryMay 31, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  N/A

  Patient problems: Bacterial Infection

  MAUDE report 17034614 ↗