CODMAN® HOLTER® RICKHAM® 821621Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10381780517771), received between Aug 2, 2022 and Oct 24, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryOct 24, 2024Material Deformation; Material Deformation

  MEDWATCH: (B)(4). "ON AN UNREPORTED DATE, THE PATIENT UNDERWENT IMPLANTATION OF AN INTRACEREBRAL VENTRICULOSTOMY (ICV) SET (UNSPECIFIED CODMAN RICKHAM, MODEL AND LOT NUMBER NOT REPORTED). ON AN UNREPORTED DATE, APPROXIMATELY 9 MONTHS PRIOR TO THE REPORT, THE PATIENT INITIATED TREATMENT WITH BRINEURA (DOSE AND FREQUENCY NOT REPORTED, INTRACEREBROVENTRICULAR) FOR THE INDICATION OF NEURONAL CEROID LIPOFUSCINOSIS. THE MOST RECENT DOSE WAS ADMINISTERED ON AN UNREPORTED DATE." "ON AN UNREPORTED DATE, THERE WAS A FAILURE OF THE RICKHAM RESERVOIR. THERE WAS COLLAPSE OF THE DOME, AND THE NEEDLE NEEDED TO BE INSERTED DIRECTLY IN THE CENTRAL HOLE OF THE TITANIUM PLATE OF THE RESERVOIR, WHICH CAUSED TECHNICAL CHALLENGES AND REQUIRED SEDATION WITH INTRAVENOUS KETAMINE AND MIDAZOLAM HYDROCHLORIDE. NO LABORATORY OR DIAGNOSTIC TEST RESULTS WERE REPORTED. THERE WERE PLANS TO CHANGE THE RESERVOIR DUE TO THE EVENT." "THE ACTION TAKEN WITH BRINEURA DUE TO THE EVENT WAS NOT REPORTED. THE OUTCOME OF THE EVENT WAS NOT REPORTED." "THE REPORTER DID NOT PROVIDE AN ASSESSMENT OF THE EVENT OF THE DEVICE FAILURE IN RELATION TO TREATMENT WITH BRINEURA. THE REPORTER ASSESSED THE EVENT AS RELATED TO THE RICKHAM R

  Patient problems: Insufficient Information; Pain

  MAUDE report 20524317 ↗
• InjuryDec 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDWATCH (B)(4). CASE STUDY REPORT (BMRN) REFERRING TO A 7 YEAR-OLD MALE SUBJECT. AN INVESTIGATOR REPORTED THIS CASE FROM THE BIOMARIN SPONSORED STUDY, CERLIPONASE ALFA OBSERVATIONAL STUDY. THE SUBJECT'S PAST MEDICAL HISTORY INCLUDED: LIP ULCERATION AND COVID-19. THE SUBJECT'S CONCURRENT CONDITIONS INCLUDED: NEURONAL CEROID LIPOFUSCINOSIS, AUTISM SPECTRUM DISORDER, DYSARTHRIA, WHEELCHAIR USER, HEART RATE IRREGULAR, SEIZURE, AND DISCOMFORT. NO ALLERGIES WERE REPORTED. CONCOMITANT MEDICATION INCLUDED: ONDANSETRON, LIDOCAINE, VALPROATE. ON (B)(6) 2019, THE SUBJECT UNDERWENT IMPLANTATION OF AN INTRACEREBRAL VENTRICULOSTOMY (ICV) SET (CODMAN & SHURTLEFF, INC-RICKHAM; MODEL 82-1623) (LOT, CATALOG, SERIAL, AND UDI NUMBERS NOT REPORTED). ON (B)(6) 2019, THE SUBJECT INITIATED TREATMENT WITH BRINEURA (300 MILLIGRAM, QOW, ICV). THE LOT NUMBER FOR BRINEURA WAS L241207. THE MOST RECENT DOSE WAS ADMINISTERED ON (B)(6) 2022. ON (B)(6) 2022 AT 9:43, THE SUBJECT EXPERIENCED A GRADE 1 DEVICE RELATED INFECTION (DEVICE RELATED INFECTION) WITH A POSITIVE CSF RESULT THAT WAS CONFIRMED ON (B)(6) 2022. THE CSF CULTURE ON (B)(6) 2022 REVEALED FEW WHITE BLOOD CELLS AND NO ORGANISMS WERE SEEN; HOWEVER, ON (B

  Patient problems: Unspecified Infection

  MAUDE report 15971901 ↗
• InjuryOct 5, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  STUDY (BIOMARIN SPONSORED STUDY, CERLIPONASE ALFA OBSERVATIONAL STUDY) MEDWATCH: (BMRN: (B)(4). ON (B)(6) 2019, THE SUBJECT UNDERWENT IMPLANTATION OF INTRACEREBRAL VENTRICULOSTOMY (ICV) SET (INTEGRA LIFE SCIENCES RICKHAM RESERVOIR 6 MM; MODEL 82-1621). ON (B)(6) 2022, THE SUBJECT WAS HOSPITALIZED FOR A PROPHYLACTIC INTRAVENTRICULAR DEVICE REPLACEMENT (DEVICE END OF SERVCIE).THE INTENSITY OF THE EVENT WAS REPORTED AS GRADE 3. THE SURGERY WENT AS PLANNED WITH NO COMPLICATIONS. NO LABORATORY OR DIAGNOSTIC TESTS WERE REPORTED. NO ADDITIONAL TREATMENT FOR THE EVENT WAS REPORTED. NO ACTION WAS TAKEN WITH BRINEURA DUE TO THE EVENT. THE OUTCOME OF THE EVENT WAS REPORTED AS RECOVERING/RESOLVING. THE INVESTIGATOR ASSESSED THE EVENT OF DEVICE END OF SERVCIE AS NOT RELATED TO TREATMENT WITH BRINEURA. THE INVESTIGATOR ASSESSED THE EVENT OF DEVICE END OF SERVCIE AS RELATED TO THE ICV DEVICE. OTHER POSSIBLE ETIOLOGICAL FACTORS INCLUDED THE DEVICE END OF LIFE. ADDITIONAL INFORMATION RECEIVED ON 22-AUG-2022: THE OUTCOME OF THE EVENT WAS UPDATED BY THE INVESTIGATOR FROM RECOVERING/RESOLVING TO RECOVERED/RESOLVED ON (B)(6) 2022. NO FURTHER INFORMATION WAS AVAILABLE. ADDITIONAL INFORMATION RECEIVED ON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544122 ↗
• InjuryAug 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A FACILITY REPORTED "AFTER INSERTION OF THE PROXIMAL CATHETER AND SUBSEQUENT RELEASE OF THE RICKHAM RESERVOIR, IT DISLOCATED FROM ITS METAL ATTACHMENT, LEAVING THE PROXIMAL CATHETER ATTACHED ONLY TO THE METAL MOUNT AND NO RESERVOIR. AS A RESULT, THE PROXIMAL CATHETER HAD TO BE REMOVED, A NEW RICKHAM ATTACHED AND THE CATHETER REPLACED." ADDITIONAL INFORMATION RECEIVED: THE PROXIMAL CATHETER WAS CONNECTED TO THE RICKHAM AND A LIGATURE WAS APPLIED AS USUAL. IT WAS IMPLANTED AS USUAL: ADVANCEMENT OF THE PROXIMAL CATHETER WITH THE RICKHAM RESERVOIR ATTACHED. THE PATIENT HAS A PRONOUNCED STITCH CANAL BLEEDING WHEREAS THIS IS PROBABLY NOT DUE TO THE MANIPULATION TO EXCHANGE THE RICKHAM RESERVOIR. FOR REPLACEMENT, THE CATHETER WAS SIMPLY PULLED BACK A BIT, THE DEFECTIVE RESERVOIR WAS REMOVED AFTER LOOSENING THE LIGATURE, A NEW RESERVOIR WAS ATTACHED ALONG WITH A NEW LIGATURE. ESTIMATED AROUND 10-15 MINUTES. A NEW RESERVOIR HAD TO BE RETRIEVED AND THE TWO RESERVOIRS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15148574 ↗