CODMAN HOLTER RICKHAM 82-1621Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886704040507), received between Mar 23, 2022 and Feb 21, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Leak/Splash” (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.

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 21, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 16409804 ↗
• InjuryMar 23, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  STUDY; PATIENT IS RECEIVING INTRAVENTRICULAR ENZYME REPLACEMENT THERAPY VIA A RICKHAM RESERVOIR. AFTER THE INTRAVENTRICULAR THERAPY ON (B)(6) 2020, THE PATIENT DEVELOPED FEVER AND VOMITING. THE DIAGNOSIS OF A BACTERIAL RICKHAM INFECTION WITH STAPH EPIDERMIDIS WAS MADE IN THE CSF ANALYSIS. ANTIBIOTIC THERAPY AND EXPLANTATION OF THE RESERVOIR FOLLOWED. FOLLOWING ANTIBIOTIC THERAPY, A NEW RESERVOIR WAS REIMPLANTED. PATIENT RECOVERED.

  Patient problems: Bacterial Infection; Fever; Vomiting

  MAUDE report 13861811 ↗
• InjuryMar 23, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  STUDY: IN A STUDCLN2, 2, THE PATIENT RECEIVED INTRAVENTRICULAR ENZYME THERAPY VIA RICKHAM RESERVOIR EVERY 14 DAYS. AFTER THE INTRAVENTRICULAR THERAPY ON (B)(6) 2020, THE PATIENT DEVELOPED FEVER AND VOMITING. AFTER LIQUID ANALYSIS, THE DIAGNOSIS OF A BACTERIAL RICKHAM INFECTION WITH MICROCOCCUS SPECIES WAS MADE IN AN EXTERNAL HOSPITAL. ANTIBIOTIC THERAPY AND EXPLANTATION OF THE RESERVOIR WAS DONE. FOLLOWING ANTIBIOTIC THERAPY, THE PATIENT'S PARENTS DISCONTINUED ENZYME REPLACEMENT THERAPY. PATIENT RECOVERED.

  Patient problems: Bacterial Infection; Fever; Vomiting

  MAUDE report 13861658 ↗
• InjuryMar 23, 2022Leak/Splash; Leak/Splash

  STUDY; PATIENT RECEIVES INTRAVENTRICULAR ENZYME THERAPY EVERY 14 DAYS VIA RICKHAM RESERVOIR AT CLN2. AFTER THE INTRAVENTRICULAR THERAPY ON (B)(6) 2019 THERE WAS A CLEAR LIQUID LEAK ON (B)(6) 2019. RICKHAM WAS REPLACED ON (B)(6) 2019.

  Patient problems: Fluid Discharge

  MAUDE report 13861651 ↗