CODMAN BACTISEAL NS0340Recalls & reported problems
Cerenovus, Inc. · CODMAN BACTISEAL Clear with Barium Stripe Catheter Kit Includes: BACTISEAL Clear with Barium Stripe Distal Catheter 120cm, BACTISEAL Clear with Barium Stripe Ventricular Catheter 15cm, Stylet, Right Angle Adapter and Information Manual · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886704045175), received between Jul 12, 2022 and Sep 6, 2023 — classified as 4 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).
1 other recall cover devices cleared under the same FDA submission (K031123); they may or may not involve this specific model.
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 Information3
- Fluid/Blood Leak1
Patient problems
- Bacterial Infection1
- Cerebrospinal Fluid Leakage1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjurySep 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryFeb 23, 2023Fluid/Blood Leak; Fluid/Blood Leak
InjuryJan 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryJul 12, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00317. A PHYSICIAN REPORTED A CERTAS VALVE (B)(4) WAS IMPLANTED VIA V-P SHUNT ON (B)(6) 2022 WITH SETTING 2 AND WAS USED WITH BACTISEAL BARIUM STRIPED CATH (NS0340). DUE TO SUSPICION OF OBSTRUCTION, SHUNT IMAGING WAS PERFORMED ON AN UNKNOWN DATE. THERE WAS NO FLOW THAT COULD BE CONFIRMED ON THE DISTAL PART OF THE VALVE. THE VALVE AND CATHETER WERE REMOVED (B)(6) 2022. THE VALVE WAS REPLACED AND IT IS UNKNOWN IF THE CATHETER WAS ALSO REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14991599 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K031123. One submission often covers many models, so check the product and lot details in each record.
- Z-1354-2021 · Mar 17, 2021 · TerminatedCODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephalus. Catalog Numb
Other Shunt, central nervous system and components devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.