HemagardRecalls & reported problems across all models
Intervascular Sas · 28 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 93
- Deaths reported
- 3
- Injuries reported
- 70
- Recalls
- 0
We found 28 models of Hemagard by Intervascular Sas in the FDA's device registry (GUDID). Together they are named in 93 adverse event reports in the FDA's MAUDE database, received between Oct 2, 2015 and May 12, 2026 — classified as 3 deaths, 70 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (43 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Hemagard problems
Device problems
- Manufacturing, Packaging or Shipping Problem43
- Adverse Event Without Identified Device or Use Problem22
- Insufficient Device Problem Information10
- Use of Device Problem7
- Off-Label Use6
- Nonstandard Device3
- Device Damaged Prior to Receipt by User2
- Leak/Splash2
Patient problems
- Blood Loss30
- Hemorrhage/Blood Loss/Bleeding20
- Stenosis14
- No Clinical Signs, Symptoms or Conditions13
- Pseudoaneurysm6
- Insufficient Information4
- No Patient Involvement4
- No Consequences Or Impact To Patient3
Hemagard models
28 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Hemagard HGKAX0808Prosthesis, Vascular Graft, Of 6mm And Greater Diameter18 reports
- Hemagard HGK1407Prosthesis, Vascular Graft, Of 6mm And Greater Diameter15 reports
- Hemagard HGK1608Prosthesis, Vascular Graft, Of 6mm And Greater Diameter6 reports
- Hemagard HGKAX100808RS35/20Prosthesis, Vascular Graft, Of 6mm And Greater Diameter6 reports
- Hemagard HGK1809Prosthesis, Vascular Graft, Of 6mm And Greater Diameter5 reports
- Hemagard HGKUT0007-40Prosthesis, Vascular Graft, Of 6mm And Greater Diameter5 reports
- Hemagard HGK0008-40Prosthesis, Vascular Graft, Of 6mm And Greater Diameter4 reports
- Hemagard HGK0008-20Prosthesis, Vascular Graft, Of 6mm And Greater Diameter3 reports
- Hemagard HGK0008-70Prosthesis, Vascular Graft, Of 6mm And Greater Diameter3 reports
- Hemagard HGKAX080606RS35/20Prosthesis, Vascular Graft, Of 6mm And Greater Diameter3 reports
- Hemagard HGKUT0008-40Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 death3 reports
- Hemagard HGK0010-100Prosthesis, Vascular Graft, Of 6mm And Greater Diameter3 reports
- Hemagard HGK0010-70Prosthesis, Vascular Graft, Of 6mm And Greater Diameter2 reports
- Hemagard HGKAX0808RS45/20Prosthesis, Vascular Graft, Of 6mm And Greater Diameter2 reports
- Hemagard HGKAX1010Prosthesis, Vascular Graft, Of 6mm And Greater Diameter2 deaths2 reports
- Hemagard HGK0006-20Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 report
- Hemagard HGK0006-40Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 report
- Hemagard HGK0007-40Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 report
- Hemagard HGK0008-100Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 report
- Hemagard HGK0010-40Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 report
- Hemagard HGK0012-40Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 report
- Hemagard HGK0014-20Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 report
- Hemagard HGK0016-40Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 report
- Hemagard HGK0020-40Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 report
- Hemagard HGK0022-40Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 report
- Hemagard HGK2211Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 report
- Hemagard HGKUT0008-20Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 report
- Hemagard HGKAX0808RS45/30Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 report
Recent Hemagard adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2026Use of Device Problem; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED TO INTERVASCULAR THAT A HOSPITAL IMPLANTED AN EXPIRED POLYESTER BIFURCATED GRAFT 3 MONTHS PAST ITS EXPIRATION DATE ON A PATIENT. NO INJURY WAS REPORTED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25147552 ↗MalfunctionMar 30, 2026Moisture or Humidity Problem
IT WAS REPORTED TO INTERVASCULAR THAT THE CUSTOMER ALLEGED THAT HUMIDITY LEVELS WERE OVER 80% FOR MORE THAN 24 HOURS AND DID REACH 100%. THE DISTRIBUTOR, (B)(4) HAD ONE OF REPS VISIT THE CUSTOMER SITE FOR AN ON-SITE INSPECTION OF THE PRODUCTS. SOME PRODUCTS HAD BUBBLING ON THE LABELLING. IT WAS DESCRIBED THAT ALL PRODUCTS FELT COLD AS IF LIKE THEY WERE DEFROSTED. IT WAS SUSPECTED THAT THE PRODUCTS WERE EXPOSED TO EXTREMELY HIGH LEVELS OF MOISTURE. THE IMPACTED PRODUCTS INCLUDE 12 INTERVASCULAR HEMAGARD AND INTERGARD GRAFTS. TWELVE SEPARATE COMPLAINTS WERE CREATED FOR EACH AFFECTED PRODUCTS. ACCORDINGLY, TWELVE INDIVIDUAL EMDR SUBMISSIONS WILL BE SUBMITTED. THIS EMDR IS PART OF A SERIES OF TWELVE EMDRS SUBMITTED FOR THE SAME EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24714422 ↗MalfunctionMar 30, 2026Moisture or Humidity Problem
IT WAS REPORTED TO INTERVASCULAR THAT THE CUSTOMER ALLEGED THAT HUMIDITY LEVELS WERE OVER 80% FOR MORE THAN 24 HOURS AND DID REACH 100%. THE DISTRIBUTOR, (B)(4) HAD ONE OF REPS VISIT THE CUSTOMER SITE FOR AN ON-SITE INSPECTION OF THE PRODUCTS. SOME PRODUCTS HAD BUBBLING ON THE LABELLING. IT WAS DESCRIBED THAT ALL PRODUCTS FELT COLD AS IF LIKE THEY WERE DEFROSTED. IT WAS SUSPECTED THAT THE PRODUCTS WERE EXPOSED TO EXTREMELY HIGH LEVELS OF MOISTURE. THE IMPACTED PRODUCTS INCLUDE 12 INTERVASCULAR HEMAGARD AND INTERGARD GRAFTS. TWELVE SEPARATE COMPLAINTS WERE CREATED FOR EACH AFFECTED PRODUCTS. ACCORDINGLY, TWELVE INDIVIDUAL EMDR SUBMISSIONS WILL BE SUBMITTED. THIS EMDR IS PART OF A SERIES OF TWELVE EMDRS SUBMITTED FOR THE SAME EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24713404 ↗InjuryMar 16, 2026Manufacturing, Packaging or Shipping Problem
InjuryMar 16, 2026Manufacturing, Packaging or Shipping Problem
InjuryMar 16, 2026Manufacturing, Packaging or Shipping Problem
InjuryMar 13, 2026Manufacturing, Packaging or Shipping Problem
InjuryMar 13, 2026Manufacturing, Packaging or Shipping Problem
InjuryMar 13, 2026Manufacturing, Packaging or Shipping Problem
THIS EVENT WAS SUBMITTED AS PART OF THE INTERVASCULAR PMCF REGISTRY ON APRIL 4, 2017, THE PATIENT WITH AORTIC OCCLUSIVE DISEASE IN THE ILIAC REGION HAD 100 PERCENT PRE-PROCEDURE STENOSIS. AN INTERGARD STANDARD AXILLO BIFEMORAL GRAFT WAS IMPLANTED, AN ILIAC STENT WAS ALSO IMPLANTED. DURING THIS PROCEDURE SUTURE HOLE BLEEDING OCCURRED AND A LOCAL HEMOSTATIC AGENT (TYPE UNKNOWN) WAS USED TO ARREST THE BLEEDING. TECHNICAL SUCCESS WAS ACHIEVED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2017 ON (B)(6) 2017, 54 DAYS AFTER THE INITIAL IMPLANT, THE PATIENT EXPERIENCED THROMBOSIS OF THE CROSSED BRANCH OF THE AXILLO-BIFEMORAL BYPASS. THE SEVERITY WAS NOTED AS MODERATE AND THE INVESTIGATOR NOTED THIS WAS POSSIBLY RELATED TO THE PROCEDURE AND POSSIBLY RELATED TO THE DEVICE. ON (B)(6) 2022, 4 YEARS, 10 MONTHS AFTER THE INITIAL IMPLANT PROCEDURE THE PATIENT EXPERIENCED PERIPROSTHETIC COLLECTION. THREE SEPARATE COMPLAINTS WERE CREATED FOR THESE THREE EVENTS. ACCORDINGLY, THREE INDIVIDUAL EMDR SUBMISSIONS WILL BE SUBMITTED FOR EACH EVENT. THIS REPORT IS THE FIRST IN A SERIES OF THREE REPORTS SUBMITTED FOR THIS PATIENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24590410 ↗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 14, 2023Off-Label Use; Off-Label Use
IT WAS REPORTED TO INTERVASCULAR THAT DURING A SURGERY THE INVOLVED GRAFT WAS USED FOR CANNULATION. AS REPORTED BY THE REPORTER "UNFORTUNATELY, IT WAS NOT SEALING. THE BLOOD WAS PASSING THROUGH GRAFT WALL IN HUGE QUANTITIES. THE WORST LEAKAGE WAS WHERE THE CANNULA WAS ATTACHED TO THE GRAFT, BUT ALSO ELSEWHERE THERE WAS SIGNIFICANT LEAKAGE. AS THEY COMPRESSED THE GRAFT WITH THE FINGERS, THE SITUATION WORSENED CONSIDERABLY. THE BLOOD LOSS WAS ENORMOUS, THEY HAD TO ASPIRATE AND RETURN TO HEART-LUNG."
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18326461 ↗InjuryDec 12, 2023Off-Label Use; Off-Label Use
IT WAS REPORTED TO INTERVASCULAR THAT DURING A SURGERY THE INVOLVED GRAFT WAS USED FOR CANNULATION. AS REPORTED BY THE REPORTER "UNFORTUNATELY, IT WAS NOT SEALING. THE BLOOD WAS PASSING THROUGH GRAFT WALL IN HUGE QUANTITIES. THE WORST LEAKAGE WAS WHERE THE CANNULA WAS ATTACHED TO THE GRAFT, BUT ALSO ELSEWHERE THERE WAS SIGNIFICANT LEAKAGE. AS THEY COMPRESSED THE GRAFT WITH THE FINGERS, THE SITUATION WORSENED CONSIDERABLY. THE BLOOD LOSS WAS ENORMOUS, THEY HAD TO ASPIRATE AND RETURN TO HEART-LUNG."
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18310207 ↗
Other Intervascular Sas products
All Intervascular Sas devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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