Tube set for irrigation, single use T0449-01Recalls & reported problems
W.O.M. World of Medicine GmbH · 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
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04056702003678), received between May 18, 2018 and May 29, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Pressure Problem” (2 reports).
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
- May 24, 2024Class IIOpen, Classified
Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery
Z-2243-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Pressure Problem2
Patient problems
- Extravasation1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2018Pressure Problem
IT WAS REPORTED THAT THE DEVICE HAD A FLUCTUATING PRESSURE, CAUSING EXTRAVASATION ON THE PATIENT.
Patient problems: Extravasation
MAUDE report 7551143 ↗MalfunctionMay 18, 2018Pressure Problem
IT WAS REPORTED THAT THE DEVICE HAD A FLUCTUATING PRESSURE DURING PROCEDURE CAUSING SHOULDER EXTRAVASATED. NO PATIENT INJURY WAS REPORTED
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7527662 ↗
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- FMS VUE II 284004Medos International Sàrl · Arthroscope562 reports
- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 reports
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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