HIGH-FLOW TUBE SET 0620050100Recalls & reported problems
W.O.M. World of Medicine GmbH · 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 04056702001520), received between Sep 21, 2021 and Sep 21, 2021 — 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Infusion or Flow Problem1
Patient problems
- Insufficient Information1
- 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.
InjurySep 21, 2021Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Infusion or Flow Problem
IT WAS REPORTED THE PROCEDURE WAS CONVERTED TO OPEN SURGERY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12506309 ↗
Other Insufflator, Endoscopic Vessel Harvesting devices
- PNEUMOCLEAR FM300W.O.M. World of Medicine GmbH · Insufflator, Endoscopic Vessel Harvesting40 reports
- PNEUMOCLEAR FM300W.O.M. World of Medicine GmbH · Insufflator, Endoscopic Vessel Harvesting8 reports
- SMOKE EVACUATION HIGH-FLOW TUBE SET 0620050250W.O.M. World of Medicine GmbH · Insufflator, Endoscopic Vessel Harvesting4 reports
- HEATED HUMIDIFIED SMOKE EVACUATION TUBE SET 0620050350W.O.M. World of Medicine GmbH · Insufflator, Endoscopic Vessel Harvesting2 reports
- HEATED HIGH-FLOW TUBE SET 0620050200W.O.M. World of Medicine GmbH · Insufflator, Endoscopic Vessel Harvesting1 report
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 13, 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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