CODMAN® BACTISEAL® 823072 (REF 82-3072)Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10381780515616), received between Jan 25, 2022 and Aug 21, 2026 — classified as 2 deaths, 43 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (19 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2026Device Dislodged or Dislocated; Migration

  Patient problems: Insufficient Information

  MAUDE report 50374206 ↗
• InjuryAug 21, 2026Device Dislodged or Dislocated; Migration

  6 of 7 reports (Same facility/surgeon, 3 patients, 7 revisions). Other Mfg report numbers:3013886523-2026-002113013886523-2026-002123013886523-2026-002133013886523-2026-002143013886523-2026-002153013886523-2026-00217This report is for Patient 3/revision 1.A facility reported that in the last 4 months he needed to do 7 revisions after a peritoneal catheter luxated and went out of the peritoneum (distal catheter migration) this with 3 different patients 1 patient needed 3 revisions, and 2 patients needed 2 revisions. 2 patients were somewhat obese, 1 had +/- normal weight. Therefore, the catheter was explanted.No additional information has been provided after several attempts.

  Patient problems: Insufficient Information

  MAUDE report 50374202 ↗
• InjuryAug 21, 2026Device Dislodged or Dislocated; Migration

  4 of 7 reports (Same facility/surgeon, 3 patients, 7 revisions). Other Mfg report numbers:3013886523-2026-002113013886523-2026-002123013886523-2026-002133013886523-2026-002153013886523-2026-002163013886523-2026-00217This report is for Patient 2/revision 1.A facility reported that in the last 4 months he needed to do 7 revisions after a peritoneal catheter luxated and went out of the peritoneum (distal catheter migration) this with 3 different patients 1 patient needed 3 revisions, and 2 patients needed 2 revisions. 2 patients were somewhat obese, 1 had +/- normal weight. Therefore, the catheter was explanted.No additional information has been provided after several attempts.

  Patient problems: Insufficient Information

  MAUDE report 50374199 ↗
• InjuryAug 21, 2026Device Dislodged or Dislocated; Migration

  3 of 7 reports (Same facility/surgeon, 3 patients, 7 revisions). Other Mfg report numbers:3013886523-2026-002113013886523-2026-002123013886523-2026-002143013886523-2026-002153013886523-2026-002163013886523-2026-00217This report is for Patient 1/revision 3.A facility reported that in the last 4 months he needed to do 7 revisions after a peritoneal catheter luxated and went out of the peritoneum (distal catheter migration) this with 3 different patients 1 patient needed 3 revisions, and 2 patients needed 2 revisions. 2 patients were somewhat obese, 1 had +/- normal weight. Therefore, the catheter was explanted.No additional information has been provided after several attempts.

  Patient problems: Insufficient Information

  MAUDE report 50374198 ↗
• InjuryAug 21, 2026Device Dislodged or Dislocated; Migration

  2 of 7 reports (Same facility/surgeon, 3 patients, 7 revisions). Other Mfg report numbers:3013886523-2026-00211,3013886523-2026-00213,3013886523-2026-00214,3013886523-2026-00215,3013886523-2026-00216,3013886523-2026-00217.This report is for Patient 1/revision 2.A facility reported that in the last 4 months he needed to do 7 revisions after a peritoneal catheter luxated and went out of the peritoneum (distal catheter migration) this with 3 different patients 1 patient needed 3 revisions, and 2 patients needed 2 revisions. 2 patients were somewhat obese, 1 had +/- normal weight. Therefore, the catheter was explanted.No additional information has been provided after several attempts.

  Patient problems: Insufficient Information

  MAUDE report 50374197 ↗
• InjuryAug 21, 2026Device Dislodged or Dislocated; Migration

  1 of 7 reports (Same facility/surgeon, 3 patients, 7 revisions). Other Mfg report numbers:3013886523-2026-00212,3013886523-2026-00213,3013886523-2026-00214,3013886523-2026-00215,3013886523-2026-00216,3013886523-2026-00217.This report is for Patient 1/revision 1.A facility reported that in the last 4 months he needed to do 7 revisions after a peritoneal catheter luxated and went out of the peritoneum (distal catheter migration) this with 3 different patients 1 patient needed 3 revisions, and 2 patients needed 2 revisions. 2 patients were somewhat obese, 1 had +/- normal weight. Therefore, the catheter was explanted.No additional information has been provided after several attempts.

  Patient problems: Insufficient Information

  MAUDE report 50374196 ↗
• MalfunctionJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Headache

  MAUDE report 50024260 ↗
• MalfunctionMay 1, 2026Improper or Incorrect Procedure or Method

  A FACILITY REPORTED THE MEDICAL TEAM IMPLANTED AN EXPIRED BACTISEAL CATHETER (ID 823072). IT WAS USED DURING SURGERY ON (B)(6) 2026 WITH EXPIRY DATE FEBRUARY 28, 2026. NO OTHER APPARENT PROBLEMS OCCURRED WITH THE PATIENT OR DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056531 ↗
• MalfunctionFeb 20, 2026Obstruction of Flow

  NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400471 ↗
• InjuryJan 21, 2026Obstruction of Flow

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 24129452 ↗
• InjuryJul 25, 2025Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT A BACTISEAL CATHETER (ID 823072) WAS IMPLANTED VIA A VENTRICULOPERITONEAL (VP) SHUNT ON (B)(6) 2025, FOR AN UNKNOWN REASON. THE CATHETER WAS IMPLANTED ALONG WITH A CERTAS VALVE (ID 828804) WITH AN INITIAL PRESSURE SET AT 1. THE PATIENT DEVELOPED SUBDURAL HEMATOMA AND SUFFERED FROM DISORIENTATION. WHEN ATTEMPTING TO CHANGE THE PRESSURE SETTING, THE POSSIBILITY OF OBSTRUCTION WAS INDICATED. X- RAY WAS TAKEN, HOWEVER, THE ISSUE COULD NOT BE FOUND FROM THE EXAMINATION. THEREFORE, THE VALVE AND THE CATHETER WERE EXPLANTED AND REPLACED ON (B)(6) 2025.

  Patient problems: Confusion/ Disorientation

  MAUDE report 22608266 ↗
• InjuryJul 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS IS 7 OF 7 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2025-00174, 3013886523-2025-00175, 3013886523-2025-00176, 3013886523-2025-00177, 3013886523-2025-00178, 3013886523-2025-00179. A PHYSICIAN REPORTED THAT PATIENTS IMPLANTED WITH THE BACTISEAL CATHETER (CATALOG #823072) DEVELOPED LATE-ONSET VENTRICULITIS. THIS CONDITION WAS OBSERVED IN SEVEN PATIENTS BETWEEN OCTOBER 2024 AND APRIL 2025. THE VENTRICULITIS MANIFESTED APPROXIMATELY ONE MONTH POST-IMPLANTATION. IN ALL REPORTED CASES, THE INFLAMMATION SUBSIDED WITHIN THREE MONTHS WITHOUT THE NEED FOR ADDITIONAL TREATMENT. THE CATHETERS REMAINED IMPLANTED IN THE PATIENT. ONE OF THE SEVEN CASES INVOLVED BLEEDING. NO SIGNS OF INFLAMMATION WERE OBSERVED AROUND THE ABDOMEN OR ON THE SKIN IN ANY OF THE CASES. THE AFFECTED PATIENTS INCLUDED INDIVIDUALS DIAGNOSED WITH BOTH SECONDARY NORMAL PRESSURE HYDROCEPHALUS (SNPH) AND IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS (INPH). ALL PATIENTS REPORTEDLY RECOVERED, AND NO FURTHER CLINICAL DETAILS WERE MADE AVAILABLE BY THE REPORTING HOSPITAL.

  Patient problems: Intracranial Hemorrhage; Unspecified Infection

  MAUDE report 22520724 ↗
• InjuryJul 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS IS 3 OF 7 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2025-00174, 3013886523-2025-00175, 3013886523-2025-00177, 3013886523-2025-00178, 3013886523-2025-00179, 3013886523-2025-00180. A PHYSICIAN REPORTED THAT PATIENTS IMPLANTED WITH THE BACTISEAL CATHETER (CATALOG #823072) DEVELOPED LATE-ONSET VENTRICULITIS. THIS CONDITION WAS OBSERVED IN SEVEN PATIENTS BETWEEN OCTOBER 2024 AND APRIL 2025. THE VENTRICULITIS MANIFESTED APPROXIMATELY ONE-MONTH POST-IMPLANTATION. IN ALL REPORTED CASES, THE INFLAMMATION SUBSIDED WITHIN THREE MONTHS WITHOUT THE NEED FOR ADDITIONAL TREATMENT. THE CATHETERS REMAINED IMPLANTED IN THE PATIENT. ONE OF THE SEVEN CASES INVOLVED BLEEDING. NO SIGNS OF INFLAMMATION WERE OBSERVED AROUND THE ABDOMEN OR ON THE SKIN IN ANY OF THE CASES. THE AFFECTED PATIENTS INCLUDED INDIVIDUALS DIAGNOSED WITH BOTH SECONDARY NORMAL PRESSURE HYDROCEPHALUS (SNPH) AND IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS (INPH). ALL PATIENTS REPORTEDLY RECOVERED, AND NO FURTHER CLINICAL DETAILS WERE MADE AVAILABLE BY THE REPORTING HOSPITAL.

  Patient problems: Unspecified Infection

  MAUDE report 22520723 ↗
• InjuryJul 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS IS 5 OF 7 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2025-00174, 3013886523-2025-00175, 3013886523-2025-00176, 3013886523-2025-00177, 3013886523-2025-00179, 3013886523-2025-00180. A PHYSICIAN REPORTED THAT PATIENTS IMPLANTED WITH THE BACTISEAL CATHETER (CATALOG #823072) DEVELOPED LATE-ONSET VENTRICULITIS. THIS CONDITION WAS OBSERVED IN SEVEN PATIENTS BETWEEN OCTOBER 2024 AND APRIL 2025. THE VENTRICULITIS MANIFESTED APPROXIMATELY ONE-MONTH POST-IMPLANTATION. IN ALL REPORTED CASES, THE INFLAMMATION SUBSIDED WITHIN THREE MONTHS WITHOUT THE NEED FOR ADDITIONAL TREATMENT. THE CATHETERS REMAINED IMPLANTED IN THE PATIENT. ONE OF THE SEVEN CASES INVOLVED BLEEDING. NO SIGNS OF INFLAMMATION WERE OBSERVED AROUND THE ABDOMEN OR ON THE SKIN IN ANY OF THE CASES. THE AFFECTED PATIENTS INCLUDED INDIVIDUALS DIAGNOSED WITH BOTH SECONDARY NORMAL PRESSURE HYDROCEPHALUS (SNPH) AND IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS (INPH). ALL PATIENTS REPORTEDLY RECOVERED, AND NO FURTHER CLINICAL DETAILS WERE MADE AVAILABLE BY THE REPORTING HOSPITAL.

  Patient problems: Unspecified Infection

  MAUDE report 22520722 ↗
• InjuryJul 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS IS 4 OF 7 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2025-00174, 3013886523-2025-00175, 3013886523-2025-00176, 3013886523-2025-00178, 3013886523-2025-00179, 3013886523-2025-00180. A PHYSICIAN REPORTED THAT PATIENTS IMPLANTED WITH THE BACTISEAL CATHETER (CATALOG #823072) DEVELOPED LATE-ONSET VENTRICULITIS. THIS CONDITION WAS OBSERVED IN SEVEN PATIENTS BETWEEN OCTOBER 2024 AND APRIL 2025. THE VENTRICULITIS MANIFESTED APPROXIMATELY ONE-MONTH POST-IMPLANTATION. IN ALL REPORTED CASES, THE INFLAMMATION SUBSIDED WITHIN THREE MONTHS WITHOUT THE NEED FOR ADDITIONAL TREATMENT. THE CATHETERS REMAINED IMPLANTED IN THE PATIENT. ONE OF THE SEVEN CASES INVOLVED BLEEDING. NO SIGNS OF INFLAMMATION WERE OBSERVED AROUND THE ABDOMEN OR ON THE SKIN IN ANY OF THE CASES. THE AFFECTED PATIENTS INCLUDED INDIVIDUALS DIAGNOSED WITH BOTH SECONDARY NORMAL PRESSURE HYDROCEPHALUS (SNPH) AND IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS (INPH). ALL PATIENTS REPORTEDLY RECOVERED, AND NO FURTHER CLINICAL DETAILS WERE MADE AVAILABLE BY THE REPORTING HOSPITAL.

  Patient problems: Sexually Transmitted Infection

  MAUDE report 22520721 ↗
• InjuryJul 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS IS 2 OF 7 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2025-00174. 3013886523-2025-00176. 3013886523-2025-00177. 3013886523-2025-00178. 3013886523-2025-00179. 3013886523-2025-00180. A PHYSICIAN REPORTED THAT PATIENTS IMPLANTED WITH THE BACTISEAL CATHETER (CATALOG #823072) DEVELOPED LATE-ONSET VENTRICULITIS. THIS CONDITION WAS OBSERVED IN SEVEN PATIENTS BETWEEN (B)(6) 2024 AND (B)(6) 2025. THE VENTRICULITIS MANIFESTED APPROXIMATELY ONE-MONTH POST-IMPLANTATION. IN ALL REPORTED CASES, THE INFLAMMATION SUBSIDED WITHIN THREE MONTHS WITHOUT THE NEED FOR ADDITIONAL TREATMENT. THE CATHETERS REMAINED IMPLANTED IN THE PATIENT. ONE OF THE SEVEN CASES INVOLVED BLEEDING. NO SIGNS OF INFLAMMATION WERE OBSERVED AROUND THE ABDOMEN OR ON THE SKIN IN ANY OF THE CASES. THE AFFECTED PATIENTS INCLUDED INDIVIDUALS DIAGNOSED WITH BOTH SECONDARY NORMAL PRESSURE HYDROCEPHALUS (SNPH) AND IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS (INPH). ALL PATIENTS REPORTEDLY RECOVERED, AND NO FURTHER CLINICAL DETAILS WERE MADE AVAILABLE BY THE REPORTING HOSPITAL.

  Patient problems: Unspecified Infection

  MAUDE report 22520706 ↗
• InjuryJul 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS IS 6 OF 7 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2025-00174, 3013886523-2025-00175, 3013886523-2025-00176, 3013886523-2025-00177, 3013886523-2025-00178, 3013886523-2025-00180. A PHYSICIAN REPORTED THAT PATIENTS IMPLANTED WITH THE BACTISEAL CATHETER (CATALOG #823072) DEVELOPED LATE-ONSET VENTRICULITIS. THIS CONDITION WAS OBSERVED IN SEVEN PATIENTS BETWEEN OCTOBER 2024 AND APRIL 2025. THE VENTRICULITIS MANIFESTED APPROXIMATELY ONE-MONTH POST-IMPLANTATION. IN ALL REPORTED CASES, THE INFLAMMATION SUBSIDED WITHIN THREE MONTHS WITHOUT THE NEED FOR ADDITIONAL TREATMENT. THE CATHETERS REMAINED IMPLANTED IN THE PATIENT. ONE OF THE SEVEN CASES INVOLVED BLEEDING. NO SIGNS OF INFLAMMATION WERE OBSERVED AROUND THE ABDOMEN OR ON THE SKIN IN ANY OF THE CASES. THE AFFECTED PATIENTS INCLUDED INDIVIDUALS DIAGNOSED WITH BOTH SECONDARY NORMAL PRESSURE HYDROCEPHALUS (SNPH) AND IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS (INPH). ALL PATIENTS REPORTEDLY RECOVERED, AND NO FURTHER CLINICAL DETAILS WERE MADE AVAILABLE BY THE REPORTING HOSPITAL.

  Patient problems: Unspecified Infection

  MAUDE report 22520705 ↗
• InjuryJul 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS IS 1 OF 7 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2025-00175 3013886523-2025-00176 3013886523-2025-00177 3013886523-2025-00178 3013886523-2025-00179. 3013886523-2025-00180. A PHYSICIAN REPORTED THAT PATIENTS IMPLANTED WITH THE BACTISEAL CATHETER (CATALOG # 823072) DEVELOPED LATE-ONSET VENTRICULITIS. THIS CONDITION WAS OBSERVED IN SEVEN PATIENTS BETWEEN (B)(6) 2025. THE VENTRICULITIS MANIFESTED APPROXIMATELY ONE-MONTH POST-IMPLANTATION. IN ALL REPORTED CASES, THE INFLAMMATION SUBSIDED WITHIN THREE MONTHS WITHOUT THE NEED FOR ADDITIONAL TREATMENT. THE CATHETERS REMAINED IMPLANTED IN THE PATIENT. ONE OF THE SEVEN CASES INVOLVED BLEEDING. NO SIGNS OF INFLAMMATION WERE OBSERVED AROUND THE ABDOMEN OR ON THE SKIN IN ANY OF THE CASES. THE AFFECTED PATIENTS INCLUDED INDIVIDUALS DIAGNOSED WITH BOTH SECONDARY NORMAL PRESSURE HYDROCEPHALUS (SNPH) AND IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS (INPH). ALL PATIENTS REPORTEDLY RECOVERED, AND NO FURTHER CLINICAL DETAILS WERE MADE AVAILABLE BY THE REPORTING HOSPITAL.

  Patient problems: Unspecified Infection

  MAUDE report 22520704 ↗
• InjuryJun 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2025-00139. EVENT FROM A POST-MARKET CLINICAL PROGRAM: A FACILITY REPORTED THAT A HAKIM VALVE (ID 823832) AND BACTISEAL CATHETER (ID 823072) WERE IMPLANTED ON (B)(6) 2021. THE PATIENT WAS TRANSFERRED TO A REHABILITATION DEPARTMENT ON (B)(6) 2021, FOR SYMPTOMATIC AND SUPPORTIVE REHABILITATION THERAPY FOLLOWING VENTRICULOPERITONEAL (VP) SHUNT PLACEMENT AND CRANIAL DEFECT REPAIR. ON (B)(6) 2022, A FOLLOW-UP CT SCAN SUGGESTED A POSSIBLE SUBCAPSULAR OR SUBPHRENIC ABSCESS IN THE RIGHT HEPATIC LOBE. CONSEQUENTLY, A VP SHUNT REMOVAL PROCEDURE WAS PERFORMED ON (B)(6) 2022. POSTOPERATIVE IMAGING REVIEW ON (B)(6) 2022, INDICATED SATISFACTORY RECOVERY, AND THE PATIENT WAS DISCHARGED ON THE SAME DAY.

  Patient problems: Liver Damage/Dysfunction; Unspecified Infection

  MAUDE report 22202941 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER: 3013886523-2025-00147. EVENT REPORTED FROM A POST-MARKET CLINICAL PROGRAM: A FACILITY REPORTED A HAKIM VALVE (ID 823832) AND A BACTISEAL CATHETER (ID 823072) WERE IMPLANTED ON (B)(6) 2021. THE PATIENT WAS ADMITTED DUE TO POOR WOUND HEALING AT THE SURGICAL SITE WITHOUT OBVIOUS CAUSE. ON (B)(6) 2021, THE PATIENT UNDERWENT WOUND DEBRIDEMENT AND SUTURING OF THE HEAD INCISION, AFTER WHICH THE WOUND HEALED WELL WITH AN UNCOMPLICATED RECOVERY. THE PATIENT WAS DISCHARGED ON (B)(6) 2021.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22202595 ↗
• InjuryJun 13, 2025Material Twisted/Bent; Material Twisted/Bent

  EVENT REPORTED FROM A POST-MARKET CLINICAL PROGRAM: A FACILITY REPORTED A BACTISEAL CATHETER KIT (ID 823072) AND A HAKIM VALVE (ID 823832) WERE IMPLANTED ON (B)(6) 2021 DUE TO HYDROCEPHALUS WITH AN INITIAL SUCCESSFUL OUTCOME. THE PATIENT NOTICED PROGRESSIVE ABDOMINAL WOUND BULGING, AND ABDOMINAL X-RAY REVEALED COILING OF THE SHUNT CATHETER. THE PATIENT WAS ADMITTED FOR ELECTIVE SURGERY, AND ON (B)(6) 2022, UNDERWENT VP SHUNT REPOSITIONING SURGERY. POSTOPERATIVELY, THE PATIENT RECEIVED ANTIBIOTIC THERAPY, FLUID REPLACEMENT, AND SYMPTOMATIC MANAGEMENT, AND WAS DISCHARGED ON (B)(6) 2022 WITH ALL IMPLANTED DEVICES REMAINING IN PLACE.

  Patient problems: Abdominal Distention

  MAUDE report 22202031 ↗
• InjuryJun 13, 2025Migration; Migration

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER: 3013886523-2025-00142. EVENT REPORTED FORM A POST-MARKET CLINICAL PROGRAM: A FACILITY REPORTED A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A ROUND ISODENSE MASS IN THE PINEAL REGION, SUGGESTIVE OF A PINEAL TUMOR WITH SIGNIFICANT HYDROCEPHALUS. THEREFORE, ON (B)(6) 2021, EMERGENCY PLACEMENT OF AN EXTERNAL VENTRICULAR DRAIN (EVD) AND INTRACRANIAL PRESSURE (ICP) MONITORING WERE PERFORMED UNDER GENERAL ANESTHESIA. THE PATIENT PRESENTED WITH PERSISTENT HEADACHE FOR ONE WEEK, AND ON (B)(6) 2021, A HAKIM VALVE (ID 823832) AND A BACTISEAL CATHETER KIT (ID 823072) WERE IMPLANTED. ON (B)(6) 2021, VENTRICULOPERITONEAL (VP) SHUNT REPOSITIONING SURGERY WAS CONDUCTED DUE TO SUBOPTIMAL CATHETER POSITIONING. THE PATIENT'S CONDITION STABILIZED POSTOPERATIVELY, AND DISCHARGE WAS COMPLETED ON (B)(6) 2021.

  Patient problems: Headache

  MAUDE report 22202028 ↗
• InjuryJun 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2025-00137. EVENT FROM A POST-MARKET CLINICAL PROGRAM: A FACILITY REPORTED THAT A HAKIM VALVE (ID 823832) AND BACTISEAL CATHETER (ID 823072) WERE IMPLANTED ON (B)(6) 2021. THE PATIENT WAS ADMITTED TWO MONTHS AFTER UNDERGOING SURGERY FOR A BRAINSTEM CAVERNOUS HEMANGIOMA. COMPREHENSIVE EXAMINATIONS WERE PERFORMED UPON ADMISSION. ON (B)(6) 2022, THE PATIENT PRESENTED WITH ALTERED MENTAL STATUS AND INTERMITTENT FEVER, SUGGESTING RETROGRADE INTRACRANIAL INFECTION SECONDARY TO ABDOMINAL INFECTION. DUE TO RECURRENT SYMPTOMS, A VP SHUNT REVISION WAS PERFORMED ON (B)(6) 2022, DURING WHICH THE ABDOMINAL END OF THE SHUNT CATHETER WAS EXTERNALIZED AND CONNECTED TO A DRAINAGE BAG. POSTOPERATIVE FINDINGS: CEREBROSPINAL FLUID (CSF) SMEAR REVEALED GRAM-POSITIVE COCCI, PROMPTING CENTRAL NERVOUS SYSTEM (CNS) ANTIBIOTIC THERAPY. BY (B)(6) 2022, THE PATIENT REPORTED NO SIGNIFICANT DISCOMFORT AND SHOWED SATISFACTORY RECOVERY, LEADING TO DISCHARGE ON THE SAME DAY. SUBSEQUENT ADMISSION (TWO MONTHS POST-SHUNT): THE PATIENT WAS READMITTED ON (B)(6) 2022, WITH PROGRESSIVE CONSCIOUSNESS DISTURBANCE OVER TWO DAYS. AN EXTERNAL HEAD CT INDICATED SU

  Patient problems: Altered State of Consciousness; Bacterial Infection; Fever

  MAUDE report 22201647 ↗
• InjuryJun 13, 2025Migration; Migration

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2025-00134. EVENT RECEIVED FROM A POST-MARKET CLINICAL PROGRAM: A FACILITY REPORTED A HAKIM VALVE (ID 823832) AND A BACTISEAL CATHETER (ID 823072) WERE IMPLANTED ON (B)(6) 2022. ONE YEAR AFTER IMPLANTATION PROCEDURE, (B)(6) 2023, THE PATIENT WAS ADMITTED DUE TO REDNESS, SWELLING, AND PAIN IN THE RIGHT UPPER ABDOMINAL WALL. A ROUTINE COLOR DOPPLER ULTRASOUND REVEALED LOCALIZED FLUID ACCUMULATION IN THE RIGHT UPPER ABDOMINAL WALL, SUGGESTING POSSIBLE DISPLACEMENT OF THE ABDOMINAL END OF THE VP SHUNT. ON (B)(6) 2023, THE PATIENT UNDERWENT VP SHUNT REVISION, EXPLORATORY LAPAROTOMY, INTESTINAL PERFORATION REPAIR, OMENTAL RELEASE, AND DRAINAGE OF AN ABDOMINAL WALL ABSCESS. INTRAOPERATIVE FINDINGS SHOWED THAT THE ABDOMINAL END OF THE SHUNT CATHETER WAS PARTIALLY TRANSECTED, AND THE DISTAL END WAS EXTERNALIZED AND CONNECTED TO AN INDWELLING NEEDLE CATHETER AND RUBBER TUBE FOR CONTINUOUS DRAINAGE. ABSCESS CULTURES IDENTIFIED STREPTOCOCCUS ANGINOSUS AND ESCHERICHIA COLI. POSTOPERATIVE MANAGEMENT INCLUDED INTENSIFIED ANTIBIOTIC THERAPY, AND FOLLOW-UP IMAGING ON (B)(6) 2023, INDICATED SATISFACTORY RECOVERY, LEADING TO THE PATIENT¿

  Patient problems: Bowel Perforation; Erythema

  MAUDE report 22201634 ↗
• InjuryMay 28, 2025Obstruction of Flow; Obstruction of Flow

  EVENT RECEIVED FROM A POST-MARKET CLINICAL PROGRAM: A FACILITY REPORTED A CODMAN BACTISEAL CATHETER (ID 823072) WAS IMPLANTED ON (B)(6) 2021 DUE TO HYDROCEPHALUS FOLLOWING INTRACRANIAL HEMORRHAGE. ON (B)(6) 2023, THE PEDIATRIC PATIENT PRESENTED WITH DIZZINESS, VOMITING, POOR APPETITE, NO FEVER OR CONVULSIONS, AND GOOD LIMB MOVEMENT, WITHOUT ANY OBVIOUS CAUSE. THE SYMPTOMS PERSISTED WITHOUT IMPROVEMENT. A COMPUTED TOMOGRAPHY (CT) SCAN PERFORMED AT ANOTHER HOSPITAL SUGGESTED OBSTRUCTION OF THE VENTRICULOPERITONEAL SHUNT, AND SURGERY WAS RECOMMENDED. CONSEQUENTLY, A "VENTRICULOPERITONEAL SHUNT UNDER VENTRICULOSCOPY" WAS PERFORMED AND THE ABDOMINAL END WAS REPLACED. POSTOPERATIVE SYMPTOMATIC AND SUPPORTIVE TREATMENT WAS PROVIDED. AFTER RECOVERY, THE PATIENT WAS DISCHARGED ON (B)(6) 2023. THE PATIENT IS IN GOOD CONDITION.

  Patient problems: Decreased Appetite; Dizziness; Vomiting

  MAUDE report 22097989 ↗