CODMAN® HAKIM® BACTISEAL® NS5524Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® HAKIM® BACTISEAL® Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with Drainage Holes and Markings · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780526797), received between Oct 8, 2025 and Oct 8, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
1 FDA recall record name this device's identifier.
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.
Reports received per month
Recalls naming this device
- Mar 17, 2021Terminated
Incorrect labeling, Catheter did not have the required holes and markings
Z-1354-2021 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Implant Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
LINKED TO MFG REPORT NUMBER: 3013886523-2021-00259. MEDWATCH MW5174410: A PATIENT REPORTED, "(B)(6) SHUNT DEVICE PLACED IN MY HEAD ON OR AROUND 2018. THREE WEEKS LATER MY HEAD BEGAN BLEEDING WHILE SITTING AT MY DESK TYPING. I IMMEDIATELY WENT TO THE DOCTOR¿S OFFICE. HIS PA SAID THE STAPLES HAD COME APART, SO SHE FIXED IT AND SENT ME ON MY WAY. EVERY DAY AFTER THAT MY HEAD HURT WORSE THAN BEFORE THE SURGERY AND CONTINUOUSLY. I CALLED THE DOCTOR'S OFFICE DAILY AND THEY TOLD ME TO KEEP TAKING THE PRESCRIBED MEDICATIONS. FINALLY, WHEN THEY REALIZED I WAS NOT BEING A BABY BUT IN SERIOUS PAIN, THEY SCHEDULED ME TO COME IN FOR A SCAN. THE SCAN SHOWED I HAD A BRAIN BLEEDING. I HAD TO RETURN TO THE HOSPITAL IMMEDIATELY FOR EMERGENCY SURGERY. AFTER THAT SURGERY I DIDN'T RETURN TO WORK I JUST STAYED HOME AND RESTED FOR SEVEN DAYS UNTIL MY FOLLOW-UP VISIT. I WAS NOT FEELING GREAT, BUT THEY KEPT SAYING I WOULD BE OK. WHEN I WENT IN FOR THE FOLLOW UP VISIT THERE WAS A SECOND AND MORE SEVERE BRAIN BLEED THIS TIME. I HAD A SECOND EMERGENCY SURGERY TO SHUT OFF THE SHUNT AND THE TUBING THAT RAN DOWN MY NECK INTO MY STOMACH. I SUFFER DAILY BECAUSE OF THIS EVENT. I AM LOSING MY SIGHT SLOWLY. I HAVE BE
Patient problems: Hemorrhage/Blood Loss/Bleeding; Implant Pain
MAUDE report 23246721 ↗
Other CATHETER, VENTRICULAR devices
- CODMAN® BACTISEAL® NS0339Integra Lifesciences Production Corporation · CATHETER, VENTRICULAR6 reports
- CODMAN® BACTISEAL® NS0340Integra Lifesciences Production Corporation · CATHETER, VENTRICULAR5 reports
- CODMAN® BACTISEAL® NS0338Integra Lifesciences Production Corporation · CATHETER, VENTRICULAR3 reports
- AESCULAP FV077PChristoph Miethke GmbH & Co. KG · CATHETER, VENTRICULAR2 reports
- CODMAN® CERTAS® Plus 828827PLIntegra LifeSciences Switzerland Sàrl · CATHETER, VENTRICULAR1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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