Hemagard HGKAX100808RS35/20Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00384401014461), received between Aug 8, 2019 and Jun 18, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2024Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  IT WAS REPORTED TO INTERVASCULAR THAT "A PATIENT HAD BEEN RECEIVED IN EMERGENCY AND HAD ALREADY UNDERGONE EVAR AND FEM FEM CROSSOVER. A FIRST GRAFT WAS TUNNELED, THERE WAS SOME TUGGING/ MANIPULATION TO GET IT IN SITU, BUT THE GRAFT WAS LEAKING HEAVILY AND JUST SEEMED REALLY POROUS WHEN FLUSHED. THE FIRST GRAFT WAS REMOVED AND REPLACED WITH ANOTHER PRODUCT FROM THE SAME MODEL. ALTHOUGH THERE WAS NO TUGGING AND VERY CAREFUL PLACEMENT, THE SAME THING HAPPENED, ALTHOUGH NOT AS MUCH AS THE FIRST GRAFT. THE SECOND GRAFT WAS REMOVED AND REPLACED WITH A STRAIGHT REINFORCED FROM A DIFFERENT MANUFACTURER.¿. IT SHOULD BE NOTED THAT THE EVENT INVOLVED TWO DEVICES, THE SECOND GRAFT ALSO BEING THE SUBJECT OF AN INITIAL EMDR. COMPLAINT #(B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564010 ↗
• InjuryJun 18, 2024Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  IT WAS REPORTED TO INTERVASCULAR THAT "A PATIENT HAD BEEN RECEIVED IN EMERGENCY AND HAD ALREADY UNDERGONE EVAR AND FEM CROSSOVER. A FIRST GRAFT WAS TUNNELED, THERE WAS SOME TUGGING/ MANIPULATION TO GET IT IN SITU, BUT THE GRAFT WAS LEAKING HEAVILY AND JUST SEEMED REALLY POROUS WHEN FLUSHED. THE FIRST GRAFT WAS REMOVED AND REPLACED WITH ANOTHER PRODUCT FROM THE SAME MODEL. ALTHOUGH THERE WAS NO TUGGING AND VERY CAREFUL PLACEMENT, THE SAME THING HAPPENED, ALTHOUGH NOT AS MUCH AS THE FIRST GRAFT. THE SECOND GRAFT WAS REMOVED AND REPLACED WITH A STRAIGHT REINFORCED FROM A DIFFERENT MANUFACTURER.¿. IT SHOULD BE NOTED THAT THE EVENT INVOLVED TWO DEVICES, THE SECOND GRAFT ALSO BEING THE SUBJECT OF AN INITIAL EMDR. COMPLAINT #(B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563856 ↗
• InjuryJun 14, 2024Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  IT WAS REPORTED TO INTERVASCULAR THAT "A PATIENT HAD BEEN RECEIVED IN EMERGENCY AND HAD ALREADY UNDERGONE EVAR AND FEM FEM CROSSOVER. A FIRST GRAFT WAS TUNNELED, THERE WAS SOME TUGGING/ MANIPULATION TO GET IT IN SITU, BUT THE GRAFT WAS LEAKING HEAVILY AND JUST SEEMED REALLY POROUS WHEN FLUSHED. THE FIRST GRAFT WAS REMOVED AND REPLACED WITH ANOTHER PRODUCT FROM THE SAME MODEL. ALTHOUGH THERE WAS NO TUGGING AND VERY CAREFUL PLACEMENT, THE SAME THING HAPPENED, ALTHOUGH NOT AS MUCH AS THE FIRST GRAFT. THE SECOND GRAFT WAS REMOVED AND REPLACED WITH A STRAIGHT REINFORCED FROM A DIFFERENT MANUFACTURER.¿ IT SHOULD BE NOTED THAT THE EVENT INVOLVED TWO DEVICES, THE SECOND GRAFT ALSO BEING THE SUBJECT OF AN INITIAL EMDR. COMPLAINT #(B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19537368 ↗
• InjuryJun 14, 2024Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  COMPLAINT #(B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19537307 ↗
• InjuryDec 4, 2019Leak/Splash

  WE RECEIVED ADDITIONAL INFORMATION FROM THE MHRA REPORT FILLED BY THE HOSPITAL CONCERNING THE EVENT: THE PATIENT REQUIRED AN EMERGENCY AXILLLO-BIFEMORAL GRAFT. A SMALL SEGMENT OF THE GRAFT WAS VERY POROUS. THE SEGMENT WAS EXCISED AND PRESERVED IN WATER BY THEATRE TEAM. THERE WERE NO SIGNIFICANT EXTRA BLOOD LOSS AND NO IMPACT ON PATIENT OUTCOME. THE INCIDENT OCCURRED ON (B)(6)2019 . THEREFORE THE GRAFT WAS NOT USED AFTER ITS EXPIRY SINCE THE EVENT TOOK PLACE ON JUNE, 29TH, 2019 AND NOT ON (B)(6)2019 AS IT WAS INITIALLY REPORTED. WE ALSO LEARNED LATER THAT THE HOSPITAL DISCARDED THE EXCISED SEGMENT BEFORE WE COULD OBTAIN IT.

  Patient problems: No Code Available

  MAUDE report 9409460 ↗
• InjuryAug 8, 2019Nonstandard Device; Manufacturing, Packaging or Shipping Problem; Nonstandard Device; Manufacturing, Packaging or Shipping Problem

  WE RECEIVED ADDITIONAL INFORMATION FROM THE MHRA REPORT FILLED BY THE HOSPITAL CONCERNING THE EVENT: THE PATIENT REQUIRED AN EMERGENCY AXILLLO-BIFEMORAL GRAFT. A SMALL SEGMENT OF THE GRAFT WAS VERY POROUS. THE SEGMENT WAS EXCISED AND PRESERVED IN WATER BY THEATRE TEAM. THERE WERE NO SIGNIFICANT EXTRA BLOOD LOSS AND NO IMPACT ON PATIENT OUTCOME. THE INCIDENT OCCURRED ON (B)(6) 2019. THEREFORE THE GRAFT WAS NOT USED AFTER ITS EXPIRY SINCE THE EVENT TOOK PLACE ON (B)(6)2019 AS IT WAS INITIALLY REPORTED. WE ALSO LEARNED LATER THAT THE HOSPITAL DISCARDED THE EXCISED SEGMENT BEFORE WE COULD OBTAIN IT.

  Patient problems: Blood Loss

  MAUDE report 8873752 ↗

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-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
• 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