Codman® CerebroFlo® 37.550.501Recalls & reported problems
Integra Lifesciences Production Corporation · Codman® CerebroFlo® EVD Catheter Set With Endexo® Technology Contains 5 Sets · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780530138), received between Dec 20, 2022 and Dec 28, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Obstruction of Flow” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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 18, 2026.
Recalls naming this device
- Apr 10, 2026Class IIOpen, Classified
Out-of-specification endotoxin result that did not meet the acceptance criteria.
Z-2173-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Obstruction of Flow1
Patient problems
- Headache1
- Insufficient Information1
- Nausea1
- Vomiting1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 20, 2022Obstruction of Flow; Obstruction of Flow
CLINICAL STUDY: "EVD CLOGGED AND REQUIRED REPLACEMENT WITH LF CEREBROFLO EVD ON (B)(6) 2022. EVD AGAIN CLOGGED ON (B)(6) 2022 AND LUMBAR DRAIN WAS PLACED. STEREOTACTIC RF EVD WAS REPLACED ON (B)(6) 2022." PATIENT STATUS: RECOVERED.
Patient problems: Insufficient Information
MAUDE report 16019578 ↗
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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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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