CODMAN BACTISEAL 82-3072Recalls & reported problems
Cerenovus, Inc. · CODMAN BACTISEAL Ventricular Catheter and Distal Catheter Kit with BACTISEAL Shunt System Contents: Ventricular Catheter 14cm (1), Distal Catheter 120cm (1), Stylet (1), RA Adapter (1), Information Manual (1) · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886704041313), received between Jul 31, 2018 and Sep 6, 2023 — classified as 6 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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
Device problems
- Insufficient Device Problem Information2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Disconnection1
- Infusion or Flow Problem1
- Obstruction of Flow1
Patient problems
- Cerebral Ventriculomegaly2
- Headache2
- Hearing Loss2
- Erythema1
- Local Reaction1
- Rash1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjurySep 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryApr 12, 2022Break; Disconnection; Break; Disconnection
A FACILITY REPORTED A (B)(6) FEMALE PATIENT VISITED THE EMERGENCY ROOM ON (B)(6) 2022 DUE TO ENLARGED VENTRICLES AND HEADACHE. A CT SCAN WAS ORDERED SHOWING THAT THE VENTRICULAR CATHETER WAS DISCONNECTED. WHEN THE PATIENT WAS SENT TO THE OPERATIVE ROOM TO RE-CONNECT THE CATHETER, THE SURGEON FOUND OUT THAT THE CATHETER WAS DEGRADED AND WHENEVER HE TRIED TO RECONNECT THE CATHETER IT GOT TORN APART. IT WAS EXPLANTED. THE CATHETER PLACEMENT WAS IN (B)(6) 2020.
Patient problems: Cerebral Ventriculomegaly; Headache
MAUDE report 14086025 ↗InjuryJan 12, 2022Obstruction of Flow; Obstruction of Flow
THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER: 3013886523-2021-00567. A PHYSICIAN REPORTED A CERTAS VALVE (828804) AND A BACTISEAL CATHETER KIT (823072) WERE IMPLANTED IN A (B)(6) YEAR-OLD MALE PATIENT VIA V-P SHUNT ON (B)(6) 2021 WITH VALVE SETTING 4. THE PATIENT DEVELOPED HEADACHE AND VALVE OBSTRUCTION WAS SUSPECTED. SHUNT CONTRAST WAS PERFORMED ON (B)(6) 2021 AND OBSTRUCTION IN THE ABDOMINAL SIDE WAS OBSERVED. THE VALVE AND CATHETER WERE REMOVED ON (B)(6) 2021, AND HAVE NOT BEEN REPLACED. THE SYMPTOMS IMPROVED AFTER REMOVAL.
Patient problems: Headache
MAUDE report 13236465 ↗InjuryNov 17, 2021Infusion or Flow Problem; Infusion or Flow Problem
InjuryJul 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
AS REPORTED BY THE SALES REP, TWO WEEKS AFTER A SHUNT PROCEDURE INVOLVING A BACTISEAL CATHETER KIT, THE PATIENT REPORTED HEARING LOSS. DOCTOR IS WONDERING IF CODMAN HAS ANY KNOWN ANTIBIOTIC TOXICITY REPORTS WHEN USING BACTISEAL.
Patient problems: Hearing Loss
MAUDE report 7736090 ↗InjuryJul 31, 2018Adverse Event Without Identified Device or Use Problem
AS REPORTED BY THE SALES REP, TWO WEEKS AFTER A SHUNT PROCEDURE INVOLVING A BACTISEAL CATHETER KIT, THE PATIENT REPORTED HEARING LOSS. DOCTOR IS WONDERING IF CODMAN HAS ANY KNOWN ANTIBIOTIC TOXICITY REPORTS WHEN USING BACTISEAL.
Patient problems: Hearing Loss
MAUDE report 7736089 ↗
Other Shunt, central nervous system and components devices
- NATUS EDS3 DRAINAGE SYSTEM NT821731CNatus Medical Incorporated · Shunt, Central Nervous System And Components1 recall208 reports
- Exacta™ 46700Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall2 deaths163 reports
- Strata® 42866Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 death160 reports
- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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