CODMAN BACTISEAL NS0339Recalls & reported problems
Cerenovus, Inc. · CODMAN BACTISEAL Clear with Barium Stripe Distal Catheter, 120cm Includes: Information Manual · Class 2 · Implant
All models of CODMAN BACTISEAL (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704045168), received between Nov 8, 2022 and Nov 8, 2022 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Confusion/ Disorientation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
1 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2022-00543. A FACILITY REPORTED A CERTAS VALVE (ID 828804) WAS IMPLANTED VIA UNKNOWN SHUNT ON UNKNOWN DATE / SETTING. THE VALVE WAS USED WITH THE SILASCON LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ). AND BACTISEAL PERITONEAL CATHETER (ID NS0339 SERIAL; UNK). ON (B)(6) 2022, THE PATIENT PRESENTED WITH DISORIENTATION AND SHUNT IMAGING WAS PERFORMED. VENTRICULAR ENLARGEMENT WAS OBSERVED; THEREFORE, SHUNT OBSTRUCTION WAS SUSPECTED, AND LUMBER CATHETER RUPTURE WAS ALSO CONFIRMED THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2022.
Patient problems: Confusion/ Disorientation
MAUDE report 15753855 ↗
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
- 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
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
- M.BLUE PLUS FX804TAesculap AG · 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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