Medline EICA58740RHRecalls & reported problems
Medline Industries, Inc. · EICA5874-01 COBLATOR II,ENT EVAC 70 XT · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888277395367), received between Jul 2, 2026 and Jul 2, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Prime” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Mar 5, 2025Open, Classified
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
Z-1547-2025 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Failure to Prime1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2026Failure to Prime
IT WAS REPORTED FROM THE CUSTOMER THAT THE TONSIL COBLATOR WAS HOOKED UP TO THE MACHINE. WHEN THE PROCEDURE WAS STARTING, THE SURGEON PRESSED THE FOOT PEDAL TO PRIME THE COBLATOR. FLUID WAS NOT RUNNING THROUGH THE TUBING, SO THEY REMOVED THE FAULTY COBLATOR FROM THE FIELD AND OPENED ANOTHER ONE TO FINISH THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25696498 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.