VascuTherm5 0P9PTVT500Recalls & reported problems
Thermotek, Inc. · VascuTherm5 Therapy System · 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 B5850P9PTVT5000), received between Aug 1, 2022 and Aug 1, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
Patient problems
- Unspecified Tissue Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 1, 2022Fluid/Blood Leak
AFTER TWO DAYS OF USE, PT COMPLAINED DEVICE WAS LEAKING AND THERE IS AN ISSUE WITH HER FOOT AND HOPES ITS NOT CAUSED FROM THE VT5. ON (B)(6), DME REPLACED UNIT WITH ANOTHER AND NO LONGER EXPERIENCED ANY FURTHER ISSUES. DR DISCONTINUED USE ON (B)(6). EVEN WAS NOT REPORTED TO MANUFACTURER UNTIL (B)(6) 2022.
Patient problems: Unspecified Tissue Injury
MAUDE report 15139869 ↗
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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
- 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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