Intergard HEW3210BRIDGERecalls & reported problems
Intervascular Sas · Intergard Woven Hemabridge Collagen Coated Vascular Graft · Class 2 · Implant
- 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 00384401001386), received between May 18, 2020 and May 19, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Nonstandard Device” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Nonstandard Device2
Patient problems
- Blood Loss2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 19, 2020Nonstandard Device; Nonstandard Device
ISOLATED DIFFUSE WEEPING/ BLEEDING FROM THE COMPLETE SMALL CONNECTION TUBE. THE PHYSICIAN CUT THE CONNECTION TUBE AS MUCH AS POSSIBLE AND COMPRESSED THE TUBE SOME TIME. THEN HE LEFT IT IN THE PATIENT AND NO NEW BLEEDING OCCURRED. THE PATIENT WAS TRANSFUSED DUE TO MASSIVE BLOOD LOSS. STATUS OF PATIENT IS STABLE AND VERY GOOD NOW.
Patient problems: Blood Loss
MAUDE report 10072904 ↗InjuryMay 18, 2020Nonstandard Device; Nonstandard Device
SEE INITIAL MFR REPORT#1640201-2020-00011. COMPLAINT (B)(4).
Patient problems: Blood Loss
MAUDE report 10065761 ↗
Other Prosthesis, Vascular Graft, Of 6mm And Greater Diameter devices
- Cardioroot HEWROOT0030Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths13 reports
- FLIXENE SLIDER GDS 25058Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall13 reports
- ADVANTA SLIDER GDS 22114Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall11 reports
- Cardioroot HEWROOT0032Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths10 reports
- FLIXENE SLIDER GDS 25129Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall9 reports
- FLIXENE SLIDER GDS 25137Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- ADVANTA SLIDER GDS 22222Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- FLIXENE SLIDER GDS 25138Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall7 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.