CODMAN® EDS3™ 821730Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® EDS3™ CSF Extenal Drainage System · Class 2
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 10381780515586), received between Nov 29, 2023 and Nov 29, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Infusion or Flow Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Infusion or Flow Problem1
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.
InjuryNov 29, 2023Infusion or Flow Problem; Infusion or Flow Problem
A PHYSICIAN REPORTED THE BURETTE OF THE EXTERNAL DRAINAGE SYSTEM (ID 821730) DID NOT DRAIN INTO THE COLLECTION BAG WHEN THE DRIP CHAMBER STOPCOCK WAS IN A DRAINAGE POSITION. THE DOCTOR HAS TO DRAIN THE BURETTE WITH A SYRNGE WHICH EXPOSES A CONTAMINATION. THE ONLY WAY IT DRAINS WAS WHEN THE DRIP CHAMBER STOPCOCK WAS IN DRAINAGE POSITION AND THE PATIENT LINE STOPCOCK WAS IN DRAINAGE POSITION TOO, THAT GENERATES A FLOW FROM THE VENTRICLES OF THE PATIENT TO THE COLLECTION BAG (ANOTHER EXPOSURE TO CONTAMINATION). IT WAS NECESSARY TO RE OPERATE THE PATIENT AND REPLACE THE DRAINAGE SYSTEM. THE PATIENT IS A CHILEAN FEMALE CLOSE TO 30 YEARS.
Patient problems: Insufficient Information
MAUDE report 18231815 ↗
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- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
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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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