VASSALLO GT Hybrid VGT14300HYBRecalls & 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 04582105830103), received between Aug 17, 2023 and Aug 18, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.
Most reported problems
Device problems
- Material Split, Cut or Torn2
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.
InjuryAug 18, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
VASSALLO GT HYBRID .014 ("THE PRODUCT") WAS USED FOR THE LESION WITH 250MM 100% STENOSIS MODERATE CALCIFICATION. ANTEGRADE FEMORAL APPROACH WAS ATTEMPTED FIRST WITH THE PRODUCT, UNSUCCESSFULLY. TIBIAL / PEDAL APPROACH WAS THEN ATTEMPTED WITH THE PRODUCT. THE PRODUCT WAS USED WITH A .018" SUPPORT CATHETER, WHICH IS COOK CXI OR CSI VIPERCROSS. THE DISTAL END OF THE PRODUCT BROKE OFF WHILE ATTEMPTING TO CROSS THE LESION. THE FOREIGN OBJECT WAS RETRIEVED WITH A BALLON CATHETER.
Patient problems: Foreign Body In Patient
MAUDE report 17571156 ↗InjuryAug 17, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
VASSALLO GT HYBRID .014 ("THE PRODUCT") WAS USED FOR THE LESION WITH 250MM 100% STENOSIS MODERATE CALCIFICATION. ANTEGRADE FEMORAL APPROACH WAS ATTEMPTED FIRST WITH THE PRODUCT, UNSUCCESSFULLY. WHILE TIBIAL / PEDAL APPROACH WAS THEN ATTEMPTED WITH THE PRODUCT, THE DISTAL END BROKE OFF INSIDE THE PATIENT. THE FOREIGN OBJECT WAS ABLE TO BE REMOVED FROM THE PATIENT BY BALLOON CATHETER. THE PRODUCT WAS USED WITH A SABER .014" BALLOON, 3.5MM X300 MM.
Patient problems: Foreign Body In Patient
MAUDE report 17565025 ↗
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- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
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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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