CODMAN® BACTISEAL® NS0343Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® BACTISEAL® Programmable Cylindrical Valve with Rickham Reservoir and Unitized SIPHONGUARD' Device and Distal Catheter Programmable in steps of 10mnm H2O (98 Pa) 30mm H2O to 200mm H2O (294Pa. 1900Pa) Includes 120cm Distal Length including SIPHONGUA · Class 2 · Implant
- 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 10381780524083), received between Oct 10, 2025 and Oct 10, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.