CODMAN® BACTISEAL® 821749Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® BACTISEAL® EVD Large Lumen Catheter Set · Class 2
All models of CODMAN BACTISEAL (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10381780518440), received between Jul 13, 2022 and Apr 3, 2026 — classified as 5 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (8 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
- May 7, 2024Open, Classified
Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
Z-2137-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak8
- Break1
- Crack1
- Fracture1
- Insufficient Device Problem Information1
- Material Puncture/Hole1
- Use of Device Problem1
Patient problems
- Cerebrospinal Fluid Leakage7
- Insufficient Information4
- Fever1
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2026Insufficient Device Problem Information
A FACILITY REPORTED AN EXPIRED BACTISEAL CATHETER (ID: 821749) WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER SEVERAL ATTEMPTS.
Patient problems: Insufficient Information
MAUDE report 24781391 ↗MalfunctionMar 20, 2026Crack; Fluid/Blood Leak
A FACILITY REPORTED AN EVD BEGAN TO LEAK AND ON INSPECTION MEDICAL STAFF FOUND A LINEAR CUT IN THE CATHETER. THERE WAS NO HARM TO THE PATIENT AND THE EVD HAS BEEN FUNCTIONING NORMALLY FOR OVER 12 HOURS PRIOR TO THE LEAK.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 24647985 ↗InjuryFeb 27, 2026Fluid/Blood Leak
A FACILITY REPORTED A BACTISEAL CATHETER (ID 821749) WAS IMPLANTED ON (B)(6) 2026. ON (B)(6) 2026, A LEAKAGE WAS OBSERVED AT THE CATHETER INTERFACE, AND IT WAS REMOVED, NOT REPLACED. THE PATIENT'S CONDITION REMAINED STABLE.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 24469594 ↗MalfunctionApr 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
MalfunctionApr 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED A BACTISEAL CATHETER (ID 821749) WAS LEAKING A MINIMAL AMOUNT OF CEREBROSPINAL FLUID (CSF) AT THE SIDE WALL OF THE END PORTION OF THE CATHETER. THE EVENT HAPPENED DURING IMPLANTATION (BEFORE IMPLANTATION SITE CLOSURE). THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO ADVERSE CONSEQUENCES REPORTED, AND THE EVENT DID NOT LEAD TO SURGICAL DELAY.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 21857955 ↗InjurySep 13, 2024Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED A BACTISEAL CATHETER (ID 821749) WAS IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024, THE PHYSICIAN FOUND A MINIMAL AMOUNT OF CEREBROSPINAL FLUID (CSF) LEAKING AT THE END OF THE CATHETER, WHERE IT WAS CONNECTED TO THE LURE-CONNECTOR. THE CATHETER WAS REMOVED ON THE SAME DAY AND A SMALL HOLE WAS FOUND AT THE END OF THE CATHETER. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED AN INFECTION-RELATED FEVER WITH A TEMPERATURE OF 39°C. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, IT WAS NOT PROVIDED.
Patient problems: Cerebrospinal Fluid Leakage; Fever; Unspecified Infection
MAUDE report 20212942 ↗MalfunctionJun 26, 2024Use of Device Problem; Use of Device Problem
A FACILITY REPORTED AN EXPIRED BACTISEAL CATHETER (ID (B)(4) WAS PLACED AFTER THE EXPIRATION DATE ON MAY 31, 2024. THE EXPIRATION DATE WAS CHECKED PRIOR TO PLACEMENT AND THE PHYSICIAN DECIDED TO PROCEED. THE DEVICE IS STILL ON THE PATIENT AND HAS NOT BEEN REMOVED. THE PATIENT DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS DUE TO THE EXPIRED DEVICE. ACCORDING TO INFORMATION PROVIDED, THE PURCHASE DATE OF THE DEVICE IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19621200 ↗InjurySep 26, 2023Fluid/Blood Leak; Fluid/Blood Leak
InjuryJul 27, 2023Fracture; Fracture
MalfunctionMar 10, 2023Material Puncture/Hole; Material Puncture/Hole
InjuryJan 13, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
A FACILITY REPORTED A BACTISEAL CATHETER (ID 821749) WAS IMPLANTED ON (B)(6) 2022. THE CATHETER WAS BROKEN AND LEAKING MINIMAL CEREBROSPINAL FLUID (CSF) NINE DAYS AFTER THE PROCEDURE. THE PATIENT HAD A LITTLE HIGHER BODY TEMPERATURE. THEREFORE, THE CATHETER WAS REMOVED AND MONITORING WAS STOPPED. THE PATIENT RECOVERED AFTER THE TREATMENT AND WAS DISCHARGED.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 16158889 ↗MalfunctionJul 13, 2022Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED A BACTISEAL CATHETER (ID 821749) WAS LEAKING MINIMAL CEREBROSPINAL FLUID (CSF) DURING THE PROCEDURE. THE LEAKAGE WAS IN THE WHITE TIP OF THE DEVICE AT THE CONNECTING POINT. THE ISSUE WAS DETECTED BEFORE IMPLANTATION SITE CLOSURE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AND 1 HOUR DELAY WAS NOTED.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 15001126 ↗
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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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