Intergard HEWAA2610080810/1Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00384401010746), received between Dec 17, 2015 and Apr 20, 2026 — classified as 2 deaths, 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Product Quality Problem

  IT WAS REPORTED TO INTERVASCULAR THAT WHEN THE DOCTOR OPENED THE PACKAGE, HE FOUND THERE WAS YELLOW DOT ON THE SURFACE OF THE GRAFT. THEN HE USED ANOTHER NEW ONE TO COMPLETE THE SURGERY. COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24922656 ↗
• DeathDec 6, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTING TO INTERVASCULAR THAT A PATIENT UNDERWENT A ACUTE DISSECTION A SURGERY. DURING THE SURGERY, THE CONNECT SITE OF THE BRANCH WAS BLEEDING. THE DOCTOR STITHCHED UP AGAIN TO COMPLETE THE SURGERY AND THE PRODUCT REMAIN IMPLANTED. THE BLEEDING OCCURRED AROUND THE CONNECTION BETWEEN THE BRANCHES AND BODY. THERE WAS DIFFERENCE BETWEEN THE FIRST AND SECOND SUTURING THAT IS TO SAY THAT THE DOCTOR SUTURED THE BLEEDING SITE SECOND TIME AS THE FIRST TIME TO STOP THE BLEEDING. THE DOCTOR USED THE SAME SUTURE DURING THESE TWO SUTURING, THE USUAL SURGICAL INSTRUMENTS WAS USED ¿BLODING CLAMPER DUITING THE OPERATION". THE PROCEDURE PROLONGED AROUND 6 HOURS AND THE TOTAL PROCEDURE LAST 12 HRS AND 40 MINS. THE AMOUNT LOSS OF BLOOD WAS AROUND 2000ML. THE PATIENT REQUIRED THE BLOOD TRANSFUSION: RED BLOOD CELL 10U, BLOOD PLATELET 2U, PLASMA 800. THE LENGTH OF STAY IN HOSPITAL WAS 10 DAYS. THE PATIENT DIED A MONTH AFTER THE OPERATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15923604 ↗
• DeathDec 1, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTING TO INTERVASCULAR THAT A PATIENT UNDERWENT A ACUTE DISSECTION A SURGERY. DURING THE SURGERY, THE CONNECT SITE OF THE BRANCH WAS BLEEDING. THE DOCTOR STITHCHED UP AGAIN TO COMPLETE THE SURGERY AND THE PRODUCT REMAIN IMPLANTED. THE BLEEDING OCCURRED AROUND THE CONNECTION BETWEEN THE BRANCHES AND BODY. THERE WAS DIFFERENCE BETWEEN THE FIRST AND SECOND SUTURING THAT IS TO SAY THAT THE DOCTOR SUTURED THE BLEEDING SITE SECOND TIME AS THE FIRST TIME TO STOP THE BLEEDING. THE DOCTOR USED THE SAME SUTURE DURING THESE TWO SUTURING, THE USUAL SURGICAL INSTRUMENTS WAS USED ¿BLODING CLAMPER DUITING THE OPERATION". THE PROCEDURE PROLONGED AROUND 6 HOURS AND THE TOTAL PROCEDURE LAST 12 HRS AND 40 MINS. THE AMOUNT LOSS OF BLOOD WAS AROUND 2000ML. THE PATIENT REQUIRED THE BLOOD TRANSFUSION: RED BLOOD CELL 10U, BLOOD PLATELET 2U, PLASMA 800. THE LENGTH OF STAY IN HOSPITAL WAS 10 DAYS. THE PATIENT DIED A MONTH AFTER THE OPERATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15895190 ↗
• MalfunctionMay 12, 2022Flaked; Flaked

  IT WAS REPORTED TO INTERVASCULAR THAT WHEN THE DOCTOR OPENED THE PACKAGE, HE FOUND THAT THERE WAS WALL SEPARATION ON THE INNER SIDE OF THE GRAFT MAIN BODY. SO HE USED THE OTHER GRAFT INSTEAD TO COMPLETE THE OPERATION. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14371237 ↗
• MalfunctionJun 17, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  SEE INITIAL MFR REPORT #: 1640201-2021-00020. COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12016244 ↗
• MalfunctionAug 8, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE SURGEON, THE DIAMETER OF THE PROSTHESIS IS NOT THE ONE INDICATED ON THE PACKAGING. IT WAS LATER CONFIRMED THAT THE GRAFT WAS IMPLANTED. THE SURGEON CUT A PIECE OF THE GRAFT AND SENT IT TO US FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8873275 ↗
• MalfunctionApr 19, 2016Device Packaging Compromised

  IT WAS REPORTED THAT THE PRODUCT PACKAGING COMPONENTS PRESENTED STAINS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5586412 ↗
• InjuryFeb 2, 2016Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING AN AORTIC ARCH SURGERY PERFORMED ON (B)(6) 2016, THE GRAFT WAS REPORTED TO BLEED SEVERELY, WHICH REQUIRED THE USE OF HEMOSTATIC DRUGS AND SUPPLIES, AND INFUSION OF BLOOD PRODUCTS. THIS LED TO A PROLONGED SURGERY. THE GRAFT REMAINED IMPLANTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Blood Loss

  MAUDE report 5403912 ↗
• InjuryDec 17, 2015Manufacturing, Packaging or Shipping Problem

  DURING A CARDIAC SURGERY PERFORMED ON (B)(6) 2015, INFILTRATION OF BLOOD WAS REPORTED. LONG TIME WAS REQUIRED TO STOP THE BLEEDING. BLOOD PRODUCTS WERE ADMINISTRATED AND THE SURGERY WAS PROLONGED BY ABOUT TWO HOURS. THE GRAFT REMAINED IMPLANTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Blood Loss

  MAUDE report 5305764 ↗
• InjuryDec 17, 2015Manufacturing, Packaging or Shipping Problem

  DURING AN CARDIAC SURGERY PERFORMED ON (B)(6) 2015, THE GRAFT WAS REPORTED TO BLEED. BLOOD UNITS WERE ADMINISTRATED TO STOP THE BLEEDING AND THE SURGERY WAS PROLONGED BY ABOUT 3 HOURS. THE GRAFT REMAINED IMPLANTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Blood Loss

  MAUDE report 5305701 ↗