Intergard IGW0028-15Recalls & reported problems
Intervascular Sas · Intergard Woven Straight Collagen Coated Vascular Graft · Class 2 · Implant
- Adverse event reports
- 7
- Deaths reported
- 2
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00384401000235), received between Nov 2, 2015 and Mar 14, 2024 — classified as 2 deaths, 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (3 reports).
1 other recall cover devices cleared under the same FDA submission (K984294); they may or may not involve this specific model.
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.
Reports received per month
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem3
- Insufficient Device Problem Information2
- Device Damaged Prior to Receipt by User1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Known Impact Or Consequence To Patient3
- Death2
- No Patient Involvement2
- Blood Loss1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 14, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED TO INTERVASCULAR THAT AFTER OPENING THE PRODUCT PACKAGING, A PINHOLE WAS OBSERVED ON THE SURFACE OF THE INTERNAL TYVEK LID. THE PRODUCT WAS WAS NOT USED AND WAS REPLACED TO COMPLETE THE OPERATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18902875 ↗DeathDec 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
WE WERE ASKED TO PROVIDE THE PRODUCT TRACEABILITY TO SUPPORT AN INVESTIGATION BY NATIONAL COMPETENT AUTHORITY FOR A PATIENT COMPLAINT ISSUE. THE ONLY INFORMATION WE KNOW IS THAT THE PATIENT SUED THE HOSPITAL AFTER HIS HOSPITAL STAY. HOWEVER WE DO NOT KNOW THE NATURE OF THE COMPLAINT AND WHETHER OUR PRODUCT IS INVOLVED IN AN ADVERSE EVENT IN THE PATIENT. IN ADDITION, WE KNOW THAT THE NATIONAL COMPETENT AUTHORITY REQUESTED TRACEABILITY FROM ALL MANUFACTURERS WHOSE PRODUCTS WERE INVOLVED IN THE SURGICAL THERAPEUTIC PROCESS.
Patient problems: Death; No Known Impact Or Consequence To Patient
MAUDE report 9428400 ↗DeathDec 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
COMPLAINT#: (B)(4).
Patient problems: Death; No Known Impact Or Consequence To Patient
MAUDE report 9416145 ↗MalfunctionNov 13, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
WHEN THE DOCTOR OPENED OUTER PACKING, THEY FOUND THE INNER PACKING IS NOT COMPLETELY SEALED. AND THEN THEY CHANGE ANOTHER ONE FOR THE OPERATION.
Patient problems: No Patient Involvement
MAUDE report 9316484 ↗MalfunctionMar 8, 2019Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User
A TRANSPORTATION PROBLEM OCCURRED. UPON DELIVERY TO THE CUSTOMER, A HOLE WAS IDENTIFIED IN THE OUTER PACKAGING AND IN ONE OF THE PRODUCT BOXES.
Patient problems: No Patient Involvement
MAUDE report 8403407 ↗MalfunctionApr 19, 2016Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT, PRIOR TO A SURGERY PERFORMED AT THE BEGINNING OF (B)(6) 2016, THE COLLAGEN COATING WAS DETACHED FROM THE GRAFT. THE INVOLVED PRODUCT WAS NOT USED. NO PATIENT OUTCOME HAS BEEN REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5586410 ↗InjuryNov 2, 2015Manufacturing, Packaging or Shipping Problem
DURING A SURGERY PERFORMED ON (B)(6) 2015, THE GRAFT WAS REPORTED TO WEEP ON ITS MIDDLE OVER A 1,5 CM2 AREA. BIOLOGICAL GLUE WAS USED AND PLASMA WAS ADMINISTRATED TO HELP COAGULATION. THE GRAFT REMAINED IMPLANTED. NO PATIENT INJURY WAS REPORTED.
Patient problems: Blood Loss
MAUDE report 5194868 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K984294. One submission often covers many models, so check the product and lot details in each record.
- Z-1282-2022 · Apr 29, 2022 · TerminatedINTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner surface. The device is available in
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.