Intergard IGK0008RS45Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00384401000778), received between Nov 28, 2018 and May 16, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K964625); 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED TO INTERVASCULAR THAT DURING AN URGENT BI-FEMORAL AXILLARY BYPASS SURGERY UNDER GENERAL ANESTHESIA, MASSIVE BLEEDING OCCURRED. AXILLARY ANASTOMOSIS WAS PERFORMED THEN IT WAS RINSED WITH HEPARINIZED SERUM, THE BLEEDING WAS OBSERVED AFTER UNCLAMPING THE AXILLARY ANASTOMOSIS AT THE NON RADIALLY SUPPORTED SEGMENT (ALL PART OF THE SEGMENT). REPORTEDLY, THE GRAFT WAS POROUS AND BEHAVED AS IF IT WAS NOT COATED. THE BLEEDING WAS DIFFUSE. THE GRAFT WAS TAKEN OUT OF THE PATIENT AND RINSED AGAIN, IT WAS NOTICED THAT THE GRAFT WAS POROUS OVER 15CM IN THE DISTAL PART. A SECOND PROSTHESIS WAS USED TO REPLACE THE POROUS SECTION, AND WAS RE-ANASTOMOSED TO THE FIRST GRAFT. CONSEQUENTLY THE SURGERY WAS PROLONGED BY AROUND 15 MINUTES. ON 2ND MAY, 2024 IT WAS INDICATED THAT THERE IS NO CONSEQUENCE ON THE PATIENT AND THAT HE IS IN GOOD HEALTH. COMPLAINT 1026513.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19330397 ↗
• InjuryMay 14, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED TO INTERVASCULAR THAT DURING AN URGENT BI-FEMORAL AXILLARY BYPASS SURGERY UNDER GENERAL ANESTHESIA, MASSIVE BLEEDING OCCURRED. AXILLARY ANASTOMOSIS WAS PERFORMED THEN IT WAS RINSED WITH HEPARINIZED SERUM, THE BLEEDING WAS OBSERVED AFTER UNCLAMPING THE AXILLARY ANASTOMOSIS AT THE NON RADIALLY SUPPORTED SEGMENT (ALL PART OF THE SEGMENT). REPORTEDLY, THE GRAFT WAS POROUS AND BEHAVED AS IF IT WAS NOT COATED. THE BLEEDING WAS DIFFUSE. THE GRAFT WAS TAKEN OUT OF THE PATIENT AND RINSED AGAIN, IT WAS NOTICED THAT THE GRAFT WAS POROUS OVER 15CM IN THE DISTAL PART. A SECOND PROSTHESIS WAS USED TO REPLACE THE POROUS SECTION, AND WAS RE-ANASTOMOSED TO THE FIRST GRAFT. CONSEQUENTLY THE SURGERY WAS PROLONGED BY AROUND 15 MINUTES. ON (B)(6) 2024 IT WAS INDICATED THAT THERE IS NO CONSEQUENCE ON THE PATIENT AND THAT HE IS IN GOOD HEALTH. COMPLAINT (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19309249 ↗
• InjuryOct 29, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER: "USE INTERGUARD ON THE RIGHT A-F BYPASS. A LARGE AMOUNT OF BLOOD LEAKED FROM THE GRAFT AFTER PASSING THROUGH THE ARTIFICIAL BLOOD VESSEL USING A SHEATH TYPE TUNNELER AND RELEASING THE GRAFT AFTER THE CENTRAL ANASTOMOSIS WAS TERMINATED AND FLOWING THE BLOOD. BLOOD LEAKAGE SEEMED TO OOZE FROM THE ENTIRE GRAFT, NOT FROM THE ANASTOMOSIS, BUT THE AMOUNT OF BLEEDING WAS LARGE AND THE LOCATION COULD NOT BE SPECIFIED. IF I COULD NOT PROCEED WITH THE PROCEDURE AND LOOKED AT THE SITUATION FOR A WHILE, THE BLOOD LEAK HAD SUBSIDED AND THE OPERATION CONTINUED. AFTER THAT, THE OPERATION WAS COMPLETED WITHOUT ANY PROBLEMS, BUT THERE IS AN OPINION THAT POSTOPERATIVE EDEMA IS A CONCERN. THIS TIME, THE LEFT A-F BYPASS WAS ALSO ANASTOMOSED WITH ANOTHER INTERGUARD, BUT THERE WAS NO PROBLEM WITH THIS, SO THE INSTITUTION DETERMINED THAT IT WAS NOT DUE TO THE PATIENT'S INFLUENCE."

  Patient problems: Blood Loss

  MAUDE report 9249566 ↗
• InjuryOct 25, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER: "USE INTERGUARD ON THE RIGHT A-F BYPASS. A LARGE AMOUNT OF BLOOD LEAKED FROM THE GRAFT AFTER PASSING THROUGH THE ARTIFICIAL BLOOD VESSEL USING A SHEATH TYPE TUNNELER AND RELEASING THE GRAFT AFTER THE CENTRAL ANASTOMOSIS WAS TERMINATED AND FLOWING THE BLOOD. BLOOD LEAKAGE SEEMED TO OOZE FROM THE ENTIRE GRAFT, NOT FROM THE ANASTOMOSIS, BUT THE AMOUNT OF BLEEDING WAS LARGE AND THE LOCATION COULD NOT BE SPECIFIED. IF I COULD NOT PROCEED WITH THE PROCEDURE AND LOOKED AT THE SITUATION FOR A WHILE, THE BLOOD LEAK HAD SUBSIDED AND THE OPERATION CONTINUED. AFTER THAT, THE OPERATION WAS COMPLETED WITHOUT ANY PROBLEMS, BUT THERE IS AN OPINION THAT POSTOPERATIVE EDEMA IS A CONCERN. THIS TIME, THE LEFT A-F BYPASS WAS ALSO ANASTOMOSED WITH ANOTHER INTERGUARD, BUT THERE WAS NO PROBLEM WITH THIS, SO THE INSTITUTION DETERMINED THAT IT WAS NOT DUE TO THE PATIENT'S INFLUENCE."

  Patient problems: Blood Loss

  MAUDE report 9238789 ↗
• InjuryNov 28, 2018Off-Label Use; Off-Label Use

  WHILE THE SURGEON WAS USING THE GRAFT AS A PERFUSION LINE, HE NOTICED THAT THE EDGE OF THE GRAFT, WHERE THERE IS NO SUPPORT COIL, WAS OOZING. BIOGLUE WAS USED TO STOP BLEEDING. IT TOOK TIME TO STOP IT AND SURGERY WAS PROLONGED. NO ADVERSE EFFECT ON THE PATIENT WAS REPORTED.

  Patient problems: Blood Loss

  MAUDE report 8110120 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964625. One submission often covers many models, so check the product and lot details in each record.

• Z-1439-2010 · Dec 9, 2009 · Terminated
  InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K9842
• Z-1427-2010 · Dec 9, 2009 · Terminated
  InterGard Knitted Collagen Coated Vascular prostheses, Catalog number: IGK1206. InterVascular SAS, France. Indicated for surgical repair, bypass or replacement of arteries in th