Intergard HEW3010BRIDGERecalls & reported problems
Intervascular Sas · Intergard Woven Hemabridge Collagen Coated Vascular Graft · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00384401001027), received between May 29, 2019 and May 29, 2019 — classified as 1 death.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- Blood Loss1
- Death1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathMay 29, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
DURING A TOTAL ARCH REPLACEMENT AND TEVAR PROCEDURE, THE SURGEON CONNECTED THE INVOLVED GRAFT WITH A 3-BRANCH HEMASHIELD GRAFT, AND THE OPERATION WAS COMPLETED. AFTER ANGIOSTOMY, BLEEDING WAS IDENTIFIED ON THE PROXIMAL PART OF THE GRAFT WHERE A NEEDLE PUNCTURE WAS PERFORMED FOR DEAIRING. AT THE COMPLETION OF THIS FIRST OPERATION, SMALL BLEEDING WAS OBSERVED BUT THE SURGEON THOUGHT IT WOULD STOP AND CLOSED THE PATIENT'S CHEST. HOWEVER, THE PATIENT'S CONDITION WAS NOT GOOD, AND A SECOND OPERATION WAS PERFORMED. ON THE SECOND EXPLORATION, BLEEDING OCCURRED IN THE AREA WHERE THE TWO GRAFTS WERE CONNECTED. VARIOUS HEMOSTATIC AGENTS, LIKE FLOSEA AND SURGICAL BERILAST, WERE APPLIED, WHICH REDUCED THE BLEEDING AMOUNT. ABOUT X20 PLEDGETED REINFORCEMENT INTERRUPTED SUTURES WERE PLACED ON THE BLOOD OOZING SURFACE OF THE GRAFT, AND FINALLY BLEEDING STOPPED. BLOOD TRANSFUSION AND HEMOSTATIC PLEDGET REPAIR WERE PERFORMED FOR 2.5 HOURS. HOWEVER, A FEW HOURS LATER, THE PATIENT HAD A HEART ARREST. ECMO WAS PERFORMED BUT THE PATIENT DIED IN A WEEK (EXACT DATE OF DEATH IS UNKNOWN). ADDITIONAL INFORMATION: TRANSFUSION : RBC 320CC 30EA, FFP 40CC 16EA. THE PATIENT HAD NO BLEEDING TENDENCY BEFORE THE OPE
Patient problems: Blood Loss; Death
MAUDE report 8649086 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page