CODMAN® BACTISEAL® 821745Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® BACTISEAL® EVD Catheter Set (1 pack) · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10381780515593), received between Oct 10, 2021 and Sep 12, 2025 — classified as 4 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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. How this data works · Data updated Oct 13, 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 that may compromise the product sterility.
Z-2136-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak3
- Crack2
- Fracture2
- Break1
- Device Contaminated During Manufacture or Shipping1
- Difficult to Remove1
- Insufficient Device Problem Information1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bacterial Infection1
- Cerebrospinal Fluid Leakage1
- Insufficient Information1
- Laceration(s)1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
MalfunctionSep 5, 2025Fracture; Leak/Splash; Fracture; Leak/Splash
MalfunctionJun 13, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
MalfunctionJun 13, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
2 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2025-00149. A FACILITY REPORTED THE WHITE CONNECTORS OF THE EVD SET WERE DAMAGED POST-SURGERY, CAUSING FLUID LEAKAGE. THE DAMAGED CONNECTORS WERE REPLACED AFTER THE INCIDENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22202033 ↗InjuryOct 31, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryAug 9, 2023Obstruction of Flow; Obstruction of Flow
N/A
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17490812 ↗MalfunctionMay 16, 2023Break; Break
A FACILITY REPORTED: "THE ICU STAFF DEVELOPMENT NURSE WAS DOING BEDSIDE TEACHING WITH THE ALLOCATED NURSE REGARDING EVDS AND HOW TO CHECK THE CONNECTIONS. APPARENTLY, THE ABOVE CONNECTION WHICH IS AT THE END OF THE INDWELLING EVD CATHETER, AND THE MONITORING SYSTEM CAME APART IN THE NURSE'S HAND. THE EVD WAS INSERTED ON (B)(6) 2023 IN THEATRE, INCIDENT OCCURRED/REPORTED ON (B)(6) 2023. MEDICAL STAFF INFORMED, AND MEDICAL STAFF REMOVED BROKEN CONNECTION AND CONNECTED A NEW CONNECTOR, FROM A NEW CSF EXTERNAL DRAINAGE SYSTEM TO PROVIDE AFFECTIVE MONITORING AND DRAINAGE SEAL." FOLLOW UP 7 DAYS POST INCIDENT AND THE PATIENT DID NOT PRESENTED SIGNS AND SYMPTOMS. THE PATIENT CONDITION IS IMPROVING POST DISCHARGE FROM ICU.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16940608 ↗InjuryNov 7, 2022Difficult to Remove; Difficult to Remove
A FACILITY REPORTED THE SILICON COVER OVER THE TROCAR OF A BACTISEAL CATHETER (ID 821745) WAS VERY DIFFICULT TO REMOVE CAUSING A SHARP INJURY TO A THEATRE SCRUB NURSE.
Patient problems: Laceration(s)
MAUDE report 15749730 ↗InjuryNov 7, 2022Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED A BACTISEAL EVD CATHETER (ID: 821745) HAD A HOLE AT THE TIP END OF THE EVD, AND THERE WAS CSF LEAKAGE COMING FROM THE CATHETER CONNECTION. THE DAMAGED PART WAS CUT OFF AND RECONNECTED THE TUBING IN STERILE MANNER. EVD REMAINED IN SITU WITH NO FURTHER LEAK. NO PROCEDURAL DELAY.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 15749015 ↗MalfunctionOct 11, 2022Fracture; Fracture
MalfunctionOct 10, 2021Material Twisted/Bent; Material Twisted/Bent
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- proGAV 2.0® FX410TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components119 reports
- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.