Intergard IGW0028-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00384401000242), received between Nov 18, 2015 and Jun 21, 2024 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Flaked” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2024Labelling, Instructions for Use or Training Problem; Inaccurate Information; Labelling, Instructions for Use or Training Problem; Inaccurate Information

  COMPLAINT #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19584852 ↗
• MalfunctionMay 24, 2023Flaked; Product Quality Problem; Flaked; Product Quality Problem

  COMPLAINT #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16992485 ↗
• InjuryJun 29, 2022Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  IT WAS REPORTED TO INTERVASCULAR (COMPLAINT #(B)(4)) THAT DURING SURGERY, A GRAFT (IGW0028-30) WAS OPENED BUT ITS LENGTH APPEARED SHORTER THAN 30 CM. THEREFORE, ANOTHER GRAFT OF THE SAME PRODUCT REFERENCE (IGW0028-30) WAS ADDED TO THE FIRST ONE TO COMPLETE THE SURGERY. THE SURGERY WAS SIGNIFICANTLY DELAYED. IT WAS SHARED THAT THERE WAS A NOTICEABLE SHORTNESS WHEN THE PRODUCTS WERE OPENED DURING THE SURGERY. THERE IS NO INFORMATION ABOUT LOT/SERIAL NUMBER OF THE GRAFT USED AND PATIENT INFORMATION. SINCE THE ALLEGATION OF SHORTNESS INVOLVES BOTH IMPLANTED PRODUCTS, ANOTHER MDR IS BEING SUBMITTED REGARDING THE SECOND DEVICE THAT WAS IMPLANTED. PLEASE NOTE THAT DUE TO THIS EVENT, THE STOCKS OF THE HOSPITAL WERE CHECKED AFTER THE OPERATION AND ANOTHER PRODUCT OF THE SAME PRODUCT REFERENCE, ALLEGEDLY SHORTER THAN 30 CM, WAS IDENTIFIED. A COMPLAINT HAS BEEN OPENED IN ORDER TO HANDLE THE EVENT (COMPLAINT #(B)(4)) AND A MDR IS BEING SUBMITTED FOR THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14855812 ↗
• MalfunctionJun 24, 2022Defective Device; Defective Device

  IT WAS REPORTED TO INTERVASCULAR (COMPLAINT (B)(4)) THAT DURING A PREVIOUS SURGERY, IT WAS OBSERVED THAT THE LENGTH OF TWO GRAFTS (MODEL IGW0028-30) WERE NOTICEABLY SHORTER THAN 30 CM. AFTER THE OPERATION, DUE TO THIS EVENT, THE HOSPITAL STOCKS WERE CHECKED AND IT WAS OBSERVED THAT A GRAFT OF THE SAME REFERENCE (IGW0028-30) , IN STOCK WAS ALSO SHORTER THAN 30 CM. TWO MDRS HAVE BEEN SUBMITTED REGARDING THE TWO FIRST GRAFTS IMPLANTED (COMPLAINT (B)(4)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14801078 ↗
• InjuryJun 24, 2022Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  IT WAS REPORTED TO INTERVASCULAR (COMPLAINT #(B)(4)) THAT DURING SURGERY, A GRAFT (IGW0028-30) WAS OPENED BUT ITS LENGTH APPEARED SHORTER THAN 30 CM. THEREFORE, ANOTHER GRAFT OF THE SAME PRODUCT REFERENCE (IGW0028-30) WAS ADDED TO THE FIRST ONE TO COMPLETE THE SURGERY. THE SURGERY WAS SIGNIFICANTLY DELAYED. IT WAS SHARED THAT THERE WAS A NOTICEABLE SHORTNESS WHEN THE PRODUCTS WERE OPENED DURING THE SURGERY. THERE IS NO INFORMATION ABOUT LOT/SERIAL NUMBER OF THE GRAFT USED AND PATIENT INFORMATION. SINCE THE ALLEGATION OF SHORTNESS INVOLVES BOTH IMPLANTED PRODUCTS, ANOTHER MDR IS BEING SUBMITTED REGARDING THE SECOND DEVICE THAT WAS IMPLANTED. PLEASE NOTE THAT DUE TO THIS EVENT, THE STOCKS OF THE HOSPITAL WERE CHECKED AFTER THE OPERATION AND ANOTHER PRODUCT OF THE SAME PRODUCT REFERENCE, ALLEGEDLY SHORTER THAN 30 CM, WAS IDENTIFIED. A COMPLAINT HAS BEEN OPENED IN ORDER TO HANDLE THE EVENT (COMPLAINT #(B)(4)) AND A MDR IS BEING SUBMITTED FOR THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14801055 ↗
• MalfunctionDec 17, 2020Flaked; Flaked

  SEE INITIAL MFR REPORT 1640201-2020-00027. COMPLAINT #(B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11029142 ↗
• MalfunctionFeb 20, 2020Flaked; Flaked

  (B)(4). AFTER THE GRAFT OPENED ON THE TABLE DURING SURGERY, THE DOCTOR DETERMINED THAT THE COLLAGEN STRUCTURE WAS PEELING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9733412 ↗
• MalfunctionJun 7, 2018Flaked; Flaked

  THE INTERIOR LUMEN OF THE VASCULAR GRAFT HAD SOME TYPE OF DEBRIS IN IT UPON OPENING THE GRAFT.

  Patient problems: No Patient Involvement

  MAUDE report 7578307 ↗
• InjuryNov 18, 2015Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE GRAFT WAS IMPLANTED ON (B)(6) 2015, ALONG WITH AN AORTIC VALVE REPLACEMENT. THE WEEK OF (B)(6) 2015, SYMPTOMS OF THROMBOSIS STARTED. ON (B)(6) 2015, THE PATIENT UNDERWENT AN ECHOCARDIOGRAM WHERE SIGN OF THROMBOSIS WERE FOUND, AND POSSIBLY CAUSED BY THE GRAFT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Thrombosis

  MAUDE report 5232134 ↗

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 · Terminated
  INTERGARD 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