HemashieldRecalls & reported problems across all models
Intervascular Sas · 51 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 149
- Deaths reported
- 1
- Injuries reported
- 61
- Recalls
- 4
We found 51 models of Hemashield by Intervascular Sas in the FDA's device registry (GUDID). Together they are named in 149 adverse event reports in the FDA's MAUDE database, received between Apr 15, 2016 and Sep 28, 2026 — classified as 1 death, 61 injuries, 87 malfunctions.
The most frequently reported specific device problem is “Product Quality Problem” (40 reports).
4 FDA recall records name at least one of these models by its device identifier.
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
Hemashield recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 14, 2022Terminated
Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40 cm) does not correspond to the (inner) sterile packaging labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Straight Vascular Graft, D: 7 mm L: 60 cm). Mislabeled product could cause a disruption of the vascular anastomosis in the long term, creating a pseudo-aneurysm
Z-0729-2022 · Root cause: Packaging process control · Recall details · FDA record ↗
- Dec 1, 2021Terminated
There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely packaged inside of the carton instead of a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1260004700; 18 mm x 9 mm; REF Number M002020851890 or a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1259882880; 18 mm x 9 mm; Ref Number M002020851890.
Z-0403-2022 · Root cause: Labeling Change Control · Recall details · FDA record ↗
- Aug 22, 2019Terminated
Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Bifurcated Graft product with the diameter size of 16 x 9 mm is likely incorrectly packed inside of the carton which was labeled to contain a HEMASHIELD PLATINUM Woven Double Velour Vascular Graft product with the diameter size of 16 x 8 mm ((REF: M00202166168P0, Lot: 18K31, SN: 1190443415, size 16 x 8 mm).
Z-2559-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jan 3, 2018Terminated
A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length).
Z-1172-2018 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
Most reported Hemashield problems
Device problems
- Product Quality Problem40
- Manufacturing, Packaging or Shipping Problem22
- Nonstandard Device16
- Material Frayed13
- Off-Label Use12
- Adverse Event Without Identified Device or Use Problem10
- Material Puncture/Hole9
- Device Contaminated During Manufacture or Shipping7
Patient problems
- No Clinical Signs, Symptoms or Conditions55
- Hemorrhage/Blood Loss/Bleeding28
- No Patient Involvement19
- Blood Loss18
- No Consequences Or Impact To Patient13
- Fungal Infection4
- Insufficient Information3
- No Information3
Hemashield models
51 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Hemashield M00202166168P0Graft, Vascular, Synthetic/Biologic Composite1 recall3 reports
- Hemashield M002020851890Graft, Vascular, Synthetic/Biologic Composite1 recall2 reports
- Hemashield M002000195140Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene1 recall2 reports
- Hemashield M002020952070Graft, Vascular, Synthetic/Biologic Composite1 recall0 reports
- Hemashield M00202175928P0Graft, Vascular, Synthetic/Biologic Composite10 reports
- Hemashield M002000196240Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene10 reports
- Hemashield M00202175208P0Graft, Vascular, Synthetic/Biologic Composite8 reports
- Hemashield M00202175210P0Graft, Vascular, Synthetic/Biologic Composite8 reports
- Hemashield M00202175430P0Graft, Vascular, Synthetic/Biologic Composite6 reports
- Hemashield M00202175132P0Graft, Vascular, Synthetic/Biologic Composite5 reports
- Hemashield M00202175410P0Graft, Vascular, Synthetic/Biologic Composite5 reports
- Hemashield M00202175926P0Graft, Vascular, Synthetic/Biologic Composite5 reports
- Hemashield M002020954080Graft, Vascular, Synthetic/Biologic Composite4 reports
- Hemashield M002020851680Graft, Vascular, Synthetic/Biologic Composite4 reports
- Hemashield M002020852010Graft, Vascular, Synthetic/Biologic Composite4 reports
- Hemashield M002020852210Graft, Vascular, Synthetic/Biologic Composite4 reports
- Hemashield M00202175428P0Graft, Vascular, Synthetic/Biologic Composite4 reports
- Hemashield M00202175826P0Graft, Vascular, Synthetic/Biologic Composite4 reports
- Hemashield M00202175830P0Graft, Vascular, Synthetic/Biologic Composite4 reports
- Hemashield M00202175924P0Graft, Vascular, Synthetic/Biologic Composite4 reports
- Hemashield M002020952080Graft, Vascular, Synthetic/Biologic Composite1 death3 reports
- Hemashield M00202175126P0Graft, Vascular, Synthetic/Biologic Composite3 reports
- Hemashield M00202175134P0Graft, Vascular, Synthetic/Biologic Composite3 reports
- Hemashield M00202175424P0Graft, Vascular, Synthetic/Biologic Composite3 reports
- Hemashield M00202175824P0Graft, Vascular, Synthetic/Biologic Composite3 reports
- Hemashield M002020951080Graft, Vascular, Synthetic/Biologic Composite2 reports
- Hemashield M002020952060Graft, Vascular, Synthetic/Biologic Composite2 reports
- Hemashield M002020952100Graft, Vascular, Synthetic/Biologic Composite2 reports
- Hemashield M002020851260Graft, Vascular, Synthetic/Biologic Composite2 reports
- Hemashield M002020851480Graft, Vascular, Synthetic/Biologic Composite2 reports
- Hemashield M00202175128P0Graft, Vascular, Synthetic/Biologic Composite2 reports
- Hemashield M00202175130P0Graft, Vascular, Synthetic/Biologic Composite2 reports
- Hemashield M00202166241P0Graft, Vascular, Synthetic/Biologic Composite2 reports
- Hemashield M00202175828P0Graft, Vascular, Synthetic/Biologic Composite2 reports
- Hemashield M00202175832P0Graft, Vascular, Synthetic/Biologic Composite2 reports
- Hemashield M00202175728AP0Graft, Vascular, Synthetic/Biologic Composite2 reports
- Hemashield M002000196270Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene2 reports
- Hemashield M002020952160Graft, Vascular, Synthetic/Biologic Composite1 report
- Hemashield M002020955070Graft, Vascular, Synthetic/Biologic Composite1 report
- Hemashield M002020851270Graft, Vascular, Synthetic/Biologic Composite1 report
- Hemashield M002020851690Graft, Vascular, Synthetic/Biologic Composite1 report
- Hemashield M002000195290Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene1 report
- Hemashield M002000195090Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene1 report
- Hemashield M00202019579P0Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene1 report
- Hemashield M00202175116P0Graft, Vascular, Synthetic/Biologic Composite1 report
- Hemashield M00202175416P0Graft, Vascular, Synthetic/Biologic Composite1 report
- Hemashield M00202175426P0Graft, Vascular, Synthetic/Biologic Composite1 report
- Hemashield M00202175432P0Graft, Vascular, Synthetic/Biologic Composite1 report
- Hemashield M00202175632P0Graft, Vascular, Synthetic/Biologic Composite1 report
- Hemashield M00202175726AP0Graft, Vascular, Synthetic/Biologic Composite1 report
- Hemashield M00202175912P0Graft, Vascular, Synthetic/Biologic Composite1 report
Recent Hemashield adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Stretched
It was reported to Intervascular that on (b)(6) 2021, an abdominal aortic graft replacement surgery was performed using Hemashield.A 20mm portion of the 20mm x 10mm graft was used to perform an I-shaped replacement in the area from the infrarenal artery to the terminal aorta. The distal end of the I-shaped graft was anastomosed to the left common iliac artery, and a Propaten 8mm ring, end-to-end anastomosed to the I-shaped portion, was anastomosed to the right external iliac artery. One week after the replacement surgery, on (b)(6) 2021, the graft had expanded to 28mm (the entire 20mm graft was expanded), and a large amount of mural thrombus was observed. Further expansion continued thereafter, reaching 32.4mm at 5 years post-surgery. Thrombus was prominently observed distal to the Propaten bifurcation.Complaint # (b)(4).
Patient problems: Insufficient Information; Thrombosis/Thrombus
MAUDE report 50911465 ↗MalfunctionJul 16, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25837784 ↗InjuryMay 25, 2026Insufficient Device Problem Information
THIS EVENT WAS SUBMITTED AS PART OF THE INTERVASCULAR PMCF REGISTRY. ON (B)(6) 2016, THE PATIENT PRESENTED WITH A LESION IN THE EXTERNAL AND COMMON ILIAC ARTERIES OF THE BILATERAL LOWER EXTREMITIES. A HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT WAS SOAKED IN HEPARIN BEFORE THE PROCEDURE, AND THE GRAFT WAS IMPLANTED VIA AORTOBIILIAC BYPASS WITHOUT ANY ISSUES. TECHNICAL SUCCESS WAS ACHIEVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2016. ON (B)(6) 2016, 4 MONTHS AND 11 DAYS AFTER THE INITIAL IMPLANT PROCEDURE, THE PATIENT EXPERIENCED A MAJOR ADVERSE LIMB EVENT (INFECTION). THE SEVERITY WAS NOTED AS SEVERE AND THE INVESTIGATOR NOTED THIS WAS CAUSALLY RELATED TO THE STUDY PROCEDURE AND CAUSALLY RELATED TO THE DEVICE. AN INTERVENTIONAL TREATMENT (SURGICAL PROCEDURE) WAS PERFORMED AND THIS ADVERSE EVENT IS NOTED AS RECOVERED WITH SEQUELAE. A SURGICAL PROCEDURE INCLUDING AXILLO-BIFEMORAL BYPASS, REMOVAL OF AORTIC GRAFT, REDO OF AXILLO-BIFEMORAL BYPASS WAS PERFORMED WITH GRAFT REINTERVENTION BUT NO AMPUTATION. THE CLINIC PROVIDED THE FOLLOWING DETAILS, "ON (B)(6) 2016 SUBJECT PRESENTED WITH FEVER, CHILLS, TACHYCARDIAC AND HYPOTENSIVE, COMPUTED TOMOGRAPHY SCAN REVEALED POSS
Patient problems: Bacterial Infection
MAUDE report 25267650 ↗InjuryMay 22, 2026Insufficient Device Problem Information
THIS EVENT WAS SUBMITTED AS PART OF THE INTERVASCULAR PMCF REGISTRY. ON (B)(6) 2016, THE PATIENT PRESENTED WITH A LESION IN THE EXTERNAL AND COMMON ILIAC ARTERIES OF THE BILATERAL LOWER EXTREMITIES. A HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT WAS SOAKED IN HEPARIN BEFORE THE PROCEDURE, AND THE GRAFT WAS IMPLANTED VIA AORTOBIILIAC BYPASS WITHOUT ANY ISSUES. TECHNICAL SUCCESS WAS ACHIEVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2016. ON (B)(6) 2016, 4 MONTHS AND 11 DAYS AFTER THE INITIAL IMPLANT PROCEDURE, THE PATIENT EXPERIENCED A MAJOR ADVERSE LIMB EVENT (INFECTION). THE SEVERITY WAS NOTED AS SEVERE AND THE INVESTIGATOR NOTED THIS WAS CAUSALLY RELATED TO THE STUDY PROCEDURE AND CAUSALLY RELATED TO THE DEVICE. AN INTERVENTIONAL TREATMENT (SURGICAL PROCEDURE) WAS PERFORMED AND THIS ADVERSE EVENT IS NOTED AS RECOVERED WITH SEQUELAE. A SURGICAL PROCEDURE INCLUDING AXILLO-BIFEMORAL BYPASS, REMOVAL OF AORTIC GRAFT, REDO OF AXILLO-BIFEMORAL BYPASS WAS PERFORMED WITH GRAFT REINTERVENTION BUT NO AMPUTATION. THE CLINIC PROVIDED THE FOLLOWING DETAILS, "ON (B)(6) 2016 SUBJECT PRESENTED WITH FEVER, CHILLS, TACHYCARDIAC AND HYPOTENSIVE, COMPUTED TOMOGRAPHY SCAN REVEALED POSS
Patient problems: Bacterial Infection
MAUDE report 25256086 ↗MalfunctionApr 24, 2026Product Quality Problem
IT WAS REPORTED TO INTERVASCULAR THAT DURING SURGERY FOR AORTIC DISSECTION, COLLAGEN DISSOLUTION WAS OBSERVED ON THE GRAFT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A STOCKED 1-BRANCH 30 GRAFT AS A REPLACEMENT, ENSURING NO ADVERSE IMPACT ON THE PATIENT¿S CONDITION. COMPLAINT#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24982471 ↗MalfunctionMar 19, 2026Product Quality Problem
IT WAS REPORTED TO INTERVASCULAR THAT WHEN THE CUSTOMER OPENED THE HEMASHIELD PLATINUM GRAFT FOR A CASE, HE WASN'T COMFORTABLE USING THE PRODUCT BECAUSE IT LOOKED DIFFERENT IN COLOR THAN THEY ARE USED TO. THEY PUT IT ASIDE AND USED A DIFFERENT GRAFT THAT THEY STATED WAS MORE WHITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24640182 ↗MalfunctionJan 9, 2026Product Quality Problem
IT WAS REPORTED TO INTERVASCULAR THAT DURING AN ASCENDING AORTA REPLACEMENT PROCEDURE, CHANGES SUGGESTIVE OF COLLAGEN DISSOLUTION WERE NOTED ON THE GRAFT SURFACE DURING TRIMMING. THE GRAFT WAS THEREFORE REPLACED WITH A NEW ONE, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THE AFFECTED GRAFT IS AVAILABLE FOR RETURN UPON REQUEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24017667 ↗MalfunctionDec 17, 2025Off-Label Use; Off-Label Use
MalfunctionOct 20, 2025Unsealed Device Packaging; Unsealed Device Packaging
COMPLAINT NUMBER: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23335342 ↗MalfunctionSep 16, 2025Material Frayed; Improper or Incorrect Procedure or Method; Material Frayed; Improper or Incorrect Procedure or Method
COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23063288 ↗MalfunctionSep 10, 2025Material Frayed; Improper or Incorrect Procedure or Method; Material Frayed; Improper or Incorrect Procedure or Method
IT WAS REPORTED TO INTERVASCULAR FROM THE HEALTH FACILITY THAT DURING A SURGICAL PROCEDURE, A DISINTEGRATION OF THE PROSTHESIS OCCURRED WHILE SUTURING. IT WAS DESCRIBED AS A FRAYING. ANOTHER PROSTHESIS WAS USED TO COMPLETE THE SURGERY. COMPLAINT #(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23017190 ↗MalfunctionAug 1, 2025Device Handling Problem; Device Handling Problem
IT WAS REPORTED TO INTERVASCULAR THAT ON (B)(6) 2025 DURING A REPAIR OF RUPTURED MYCOTIC ANEURYSM OF THORACIC AND ABDOMINAL AORTA, USING 16MM RIFAMPIN SOAKED HEMAHSIELD GRAFT, THE CONCERNED GRAFT WAS INCORRECTLY OPENED AND HANDLED ONTO THE STERILE FIELD WITH THE NON-STERILE PACKAGING, DUE TO MISINTERPRETATION OF PACKAGING. THE SEQUENCE OF EVENTS WAS CONFIRMED AS FOLLOWS: "THE CLEAR PLASTIC ANTIMOISTURE POUCH THAT HAS THE YELLOW WARNING LABEL "POUCH IS NOT A STERILE BARRIER" WAS OPENED OUTSIDE THE STERILE FIELD. HOWEVER, THE NON-STERILE OUTER TRAY PACKAGE WAS PLACED IN THE STERILE FIELD. THE STERILE INNER TRAY PACKAGE WAS PLACED IN THE STERILE FIELD AND GRAFT ITSELF WAS STERILE." THIS PATIENT WAS ALREADY UNDER ANTIBIOTICS TREATMENT AND NEEDED TO CONTINUE ANTIBIOTICS DUE TO THE PREOPERATIVE DIAGNOSIS OF MYCOTIC ANEURYSM REGARDLESS OF THE CONTAMINATION ERROR MADE BY THE NURSE. NO PROCEDURAL DELAY WAS REPORTED. THE PATIENT¿S MEDICAL FOLLOW-UP IS PLANNED AT 1, 6 AND 12 MONTHS. AS OF TODAY, NO HARM TO THE PATIENT WAS REPORTED. THE CUSTOMER IS A LONG TIME USER OF INTERVASCULAR PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22684576 ↗MalfunctionJul 7, 2025Material Frayed; Material Frayed
MalfunctionJun 4, 2025Nonstandard Device; Product Quality Problem; Nonstandard Device; Product Quality Problem
IT WAS REPORTED TO INTERVASCULAR THAT DURING THE PREPARATION FOR THE SURGERY, A DISCOLORATION WAS FOUND ON A PART OF THE PRODUCT LIKELY DUE TO THE MELTING OF COLLAGEN. THE SURGERY WAS COMPLETED WITH A HEMASHIELD 4-BRANCH (REF. M00202175926P0, SN (B)(6) AVAILABLE AT THE HOSPITAL, AND IT HAD NO EFFECT ON THE PATIENT'S CONDITION OR THE SURGICAL PROCEDURE. THE INVOLVED PRODUCT IS AVAILABLE FOR EXAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22140598 ↗InjuryMay 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED TO INTERVASCULAR THAT A PATIENT WAS PRESENTING WITH RECURRENT PERIPROSTHETIC PURULENT COLLECTIONS, WHICH WERE STERILE AFTER CULTURE. GIVEN THE RECURRENCE OF THESE EVENTS, A HYPERSENSITIVITY REACTION TO VASCULAR PROSTHESES HAS BEEN SUGGESTED BY THE HOSPITAL. THE PATIENT HAS THREE PROSTHESES MANUFACTURED BY INTERVESCULAR: ONE HEMASHIELD PRODUCT WHICH IS THE SUBJECT OF THIS REPORT. -THE TWO OTHER DEVICES ARE INTERGARD SILVER GRAFTS. COMPLAINT # (B)(4).
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 21970615 ↗
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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