VASSALLO GT Support VGT14300XSPRecalls & reported problems
Filmec K.K. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04582105830080), received between Feb 29, 2024 and Mar 6, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Peeled/Delaminated” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Peeled/Delaminated2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 6, 2024Peeled/Delaminated; Peeled/Delaminated
VASSALLO GT .014" ("THE PRODUCT") WAS USED WITH THE AURYON ATHERECTOMY CATHETER IN THE PATIENT'S BODY, AND IT WAS VERY STICKY AND TIGHT WHEN REMOVING AURYON. GREEN FLAKING APPEARED WHEN WET TELFA WIPED THE PRODUCT. THE PROCEDURE WAS COMPLETED BY SWITCHING TO A DIFFERENT WIRE AND THERE WAS NO HEALTH HAZARD ON THE PATIENT'S BODY.
Patient problems: Foreign Body In Patient
MAUDE report 18849561 ↗InjuryFeb 29, 2024Peeled/Delaminated; Peeled/Delaminated
VASSALLO GT .014" ("THE PRODUCT") WAS USED WITH THE AURYON ATHERECTOMY CATHETER IN THE PATIENT'S BODY, AND IT WAS VERY STICKY AND TIGHT WHEN REMOVING AURYON. GREEN FLAKING APPEARED WHEN WET TELFA WIPED THE PRODUCT. THE PROCEDURE WAS COMPLETED BY SWITCHING TO A DIFFERENT WIRE AND THERE WAS NO HEALTH HAZARD ON THE PATIENT'S BODY.
Patient problems: Foreign Body In Patient
MAUDE report 18813446 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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