CODMAN® 821735Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780518372), received between Sep 6, 2022 and May 28, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Disconnection” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K061568); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097074 ↗
• InjuryMay 9, 2024Disconnection; Material Split, Cut or Torn; Disconnection; Material Split, Cut or Torn

  A FACILITY REPORTED A PATIENT HAD A PROCEDURE ON (B)(6) 2024 EVENING TO SET UP AN EXTERNAL DRAINAGE SYSTEM: THE PATIENT (WHO HAD ARMS AND LEGS RESTRAINED) WAS FOUND WITHOUT THE HEAD BANDAGE AND EXTERNAL DERIVATION WAS OUT. PART OF THE CATHETER HAD FALLEN IN THE BANDAGE AND THE TUBE WAS ALMOST REMOVED. THE BANDAGE WAS FULL OF CEREBROSPINAL FLUID AND THE EVD DID NOT DRAIN A LOT SINCE THE PATIENT CAME BACK FROM THE OPERATING ROOM. MEDICAL STAFF STATED: "WE DON'T KNOW WHY A PART OF THE TUBE WAS FOUND IN THE BANDAGE BUT IT CANNOT HAVE BEEN RIPPED OFF BY THE PATIENT AS THE SECTION WAS CLEAN AND STRAIGHT." THE PATIENT HAD TO UNDERGO AN EMERGENCY SCAN AND A NEW PROCEDURE IN OPERATIVE ROOM FOR SET UP A NEW EVD. THEY NOTICED PATIENT HAD FEVER, TREATED WITH PROPHYLACTIC ANTIBIOTIC.

  Patient problems: Fever

  MAUDE report 19282315 ↗
• MalfunctionSep 6, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A FACILITY REPORTED TWO MISSING PARTS (FEMALE LUER LOCK AND LUER LOCK CONNECTOR CAP) IN THE KIT (EDS3 CLEAR VENT CATH). WITHOUT THESE PARTS, CATHETER COULD NOT BE CONNECTED TO MONITORING OR TO SYSTEM TO COLLECT CSF. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT. NO PATIENT INJURY REPORTED; HOWEVER, THE EVENT LED TO MORE THAN ONE HOUR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15363854 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061568. One submission often covers many models, so check the product and lot details in each record.

• Z-0091-2015 · Sep 15, 2014 · Terminated
  Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar p
• Z-0089-2015 · Sep 15, 2014 · Terminated
  Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 Indicated for draining cerebrospinal fluid (CFS) and other fluids of simil
• Z-0090-2015 · Sep 15, 2014 · Terminated
  Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: 82-1731 Indicated for draining cerebrospinal fluid (CFS) and other fluids of simil