Artegraft Vascular GraftRecalls & reported problems across all models

We found 15 models of Artegraft Vascular Graft by Lemaitre Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Sep 17, 2015 and Dec 10, 2024 — classified as 7 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 still open.

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

Artegraft Vascular Graft 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.

1. Feb 10, 2026Class IIOpen, Classified

   Labeling mix-up resulting in the incorrect lot outer packaging of product.

   Z-1574-2026 · Root cause: Labeling Change Control · Recall details · FDA record ↗

2. Sep 25, 2025Class IIOpen, Classified

   The device was incorrectly packed in the wrong size labeled outer packaging.

   Z-0289-2026 · Root cause: Packaging change control · Recall details · FDA record ↗

3. Sep 2, 2025Class IIOpen, Classified

   The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.

   Z-0034-2026 · Root cause: Nonconforming Material/Component · names 15 of these models · Recall details · FDA record ↗

Most reported Artegraft Vascular Graft problems

Artegraft Vascular Graft models

15 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Artegraft Vascular Graft AG 740

  Tissue Graft Of 6mm And Greater
  2 recalls5 reports
• Artegraft Vascular Graft AG 1015

  Tissue Graft Of 6mm And Greater
  2 recalls0 reports
• Artegraft Vascular Graft AG 636

  Tissue Graft Of 6mm And Greater
  1 recall5 reports
• Artegraft Vascular Graft AG 640

  Tissue Graft Of 6mm And Greater
  1 recall4 reports
• Artegraft Vascular Graft AG 730

  Tissue Graft Of 6mm And Greater
  1 recall3 reports
• Artegraft Vascular Graft AG 630

  Tissue Graft Of 6mm And Greater
  1 recall2 reports
• Artegraft Vascular Graft AG 745

  Tissue Graft Of 6mm And Greater
  1 recall2 reports
• Artegraft Vascular Graft AG 750

  Tissue Graft Of 6mm And Greater
  1 recall2 reports
• Artegraft Vascular Graft AG 616

  Tissue Graft Of 6mm And Greater
  1 recall1 report
• Artegraft Vascular Graft AG 735

  Tissue Graft Of 6mm And Greater
  1 recall1 report
• Artegraft Vascular Graft AG 645

  Tissue Graft Of 6mm And Greater
  1 recall0 reports
• Artegraft Vascular Graft AG 715

  Tissue Graft Of 6mm And Greater
  1 recall0 reports
• Artegraft Vascular Graft AG 840

  Tissue Graft Of 6mm And Greater
  1 recall0 reports
• Artegraft Vascular Graft AG 1030

  Tissue Graft Of 6mm And Greater
  1 recall0 reports
• Artegraft Vascular Graft AG 830

  Tissue Graft Of 6mm And Greater
  1 recall0 reports

Recent Artegraft Vascular Graft adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2024

  THE GRAFT WAS SPATULATED AND SEWN INTO THE VEIN USING RUNNING 6-0 PROLENE. AT THE END OF THE PROCEDURE, THE VESSELS AND GRAFT WERE FLUSHED WITH GOOD FLOW. ONE REPAIR STITCH WAS PLACED IN EACH OF THE ARTERIAL AND VENOUS ANASTOMOSES. THERE WAS STRONG FLOW IN THE GRAFT TO THE MIDPORTION OF THE TUNNELED AREA BUT VERY LITTLE FLOW INTO THE VENOUS AREA. THE TUNNEL WAS ENLARGED MANUALLY FROM BOTH DIRECTIONS TO ENSURE THAT THERE WAS NO STRICTURE OF THE GRAFT. THERE WAS NOT. THE GRAFT WAS OPENED, AND A CORONARY DILATOR WAS PASSED THROUGH THE GRAFT AS WAS A FOGARTY BALLOON CATHETER. NO CLOT OR OTHER PROBLEM WAS NOTED. A INCISION WAS MADE OVER THE POINT OF THE PULSE DIFFERENTIAL, AND THE GRAFT WAS NOTED TO BE BRUISED APPEARING. THE GRAFT WAS OPENED, AND A DISSECTION FLAP WAS SEEN WITHIN THE GRAFT. A SMALL PORTION OF THE GRAFT WAS EXCISED AND RE-ANASTOMOSED, BUT THIS DID NOT FIX THE PROBLEM. LEFT OVARY GRAFT MATERIAL FROM THE ORIGINAL TRIMMING OF THE GRAFT WAS THEN USED TO REPLACE MOST OF THE ARTERIAL PORTION OF THE GRAFT. IT WAS SEWN INTO THE VENOUS AREA AT THE COUNTER-INCISION AND WAS SEWN INTO THE ARTERIAL PORTION APPROXIMATELY 2 CM FROM THE ANASTOMOSIS. FOLLOWING THIS, THERE WAS EXCELLENT F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20891711 ↗
• InjuryApr 3, 2024Material Rupture; Material Rupture

  THE GRAFT WAS ORIGINALLY IMPLANTED BY DR. (B)(6) ON (B)(6) 2023. THE IMPLANT PROCEDURE PERFORMED WAS "FEM POP", LOWER LIMB BYPASS AND THE DEVICE WAS "CHECKED" BEFORE THE PROCEDURE. THE PATIENT COMPLAINED OF PAIN IN R GROIN ON FRIDAY (B)(6) 2024, WAS CLEARED AND SENT HOME. THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2024 AND DR. (B)(6) PERFORMED SURGERY TO REPAIR THE RUPTURED GRAFT WITH STENTS. NO PATIENT INJURY OR CURRENT STATUS WAS REPORTED. PRODUCT REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: Rupture

  MAUDE report 19036947 ↗
• MalfunctionJan 10, 2024

  GRAFT APPEARED MUCH SMALLER THAN STATED ON PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18484423 ↗
• MalfunctionMar 18, 2022Obstruction of Flow; Obstruction of Flow

  THE SALES REPRESENTATIVE ATTENDED A CASE ON (B)(6) 2022 AT (B)(6) GENERAL HOSPITAL. THE SURGEON USED A VIABHAN STENT TO CONNECT ARTEGRAFT COLLAGEN VASCULAR GRAFT ON THE VENOUS SIDE AND SUTURED THE ARTERIAL SIDE. PATIENT WAS DISCHARGED AS PLANNED. THE SALES REPRESENTATIVE FOLLOWED UP WITH THE SURGEON ON 2/17/2022 AFTER THE POST PROCEDURE FOLLOW-UP (USING DOPLER ULTRASOUND) AND WAS INFORMED THAT THE PATIENTS GRAFT HAD THROMBOSED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13807119 ↗
• MalfunctionJan 7, 2022Material Integrity Problem; Material Integrity Problem

  PATIENT HAD A LEFT ARM BRACHIAL ARTERY TO BRACHIAL VEIN ARTEGRAFT IMPLANTED (B)(6) 2021. ON (B)(6) 2021, IT WAS REPORTED CLOTTED BY THE DIALYSIS CENTER SO THE DOCTOR PERFORMED A THROMBECTOMY AND PULLED OUT THE CLOT FROM THE ARTERIAL END. THE GRAFT WAS SUCCESSFULLY ACCESSED 3-5 TIMES. ON (B)(6) 2021 IT WAS AGAIN CLOTTED AND THE DOCTOR PERFORMED A SECOND THROMBECTOMY/EXPLORATION AND AGAIN FOUND A CLOT ON THE ARTERIAL END. THE DOCTOR STATED THAT IT LOOKED LIKE ACCESS SITES WERE CLOSER TO THIS END OF GRAFT. VENOUS END WAS OPEN. DURING THE PROCEDURE THE DOCTOR WAS ABLE TO SEE THAT THE MID PORTION OF THE GRAFT LOOKED LIKE THE WALLS OF GRAFT HAD SEPARATED. HE SAID IT APPEARED THAT THE INTIMAL WALL WAS JUST" FREE-FLOATING" LIKE A STRAW WITHIN THE LUMEN OF THE GRAFT. HE WAS WORRIED THAT THE GRAFT WAS FAULTY SO HE LIGATED THE GRAFT. THE PATIENT CONTINUES DIALYSIS ON A CATHETER NOW AND WILL HAVE A NEW GRAFT IMPLANTED IN (B)(6).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13196877 ↗
• MalfunctionJun 7, 2021Material Puncture/Hole; Material Puncture/Hole

  THE GRAFT WAS IMPLANTED ON (B)(6) 2021 FEMORAL TO POPLITEAL BYPASS PROCEDURE. NO ISSUES OCCURRED DURING THE PROCEDURE. THE MALFUNCTION WAS DETECTED ON (B)(6) 2021. THIS GRAFT WAS NOT USED FOR ACCESS. THE PATIENT WAS BLEEDING OUT THROUGH A HOLE IN THE GRAFT ABOUT 6CM SOUTH OF PROXIMAL ANASTOMOSIS. THE SURGEON SURGICALLY REPAIRED THE HOLE WITH PTFE. THE PATIENT WAS REPORTED AS "DOING FINE" AFTER THE PROCEDURE.

  Patient problems: Hematoma

  MAUDE report 11952288 ↗
• InjuryApr 28, 2021Contamination; Contamination

  THE DOCTOR MENTIONED TO A SALES REPRESENTATIVE THAT HE WOULD NO LONGER BE UTILIZING ARTEGRAFT IN THE GROIN/LEG AS HE HAD 4 PATIENTS IN THE LAST FEW MONTHS THAT GET INFECTED AND THE GRAFT DISINTEGRATED. UPON REVIEW OF THE DETAILS, IT WAS LATER UPDATED THAT ONLY 2 PATIENTS WERE IDENTIFIED AS HAVING ARTEGRAFT IMPLANTED. THE FOLLOWING PATIENT INFORMATION WAS PROVIDED FOR PATIENT 1: LEFT LEG GROOVE AVG UTILIZING AN ARTEGRAFT 5 MM GRAFT ON (B)(6) 2020,· EMERGENT EXPLORATION, LEFT COMMON FEMORAL WITH EXCISION OF AV GRAFT ON (B)(6) 2020. BELOW KNEE AMPUTATION BEFORE THE GRAFT WAS IMPLANTED AND THEN ABOVE KNEE AMPUTATION AFTER THE GRAFT IMPLANT, LIKELY DUE TO THE COMPLICATIONS.

  Patient problems: Bacterial Infection; Post Operative Wound Infection

  MAUDE report 11737713 ↗
• MalfunctionApr 20, 2021Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  A LEMAITRE SALES REPRESENTATIVE RECEIVED AN EMAIL NOTIFICATION FROM THE HOSPITAL STATING "RECENTLY THE STAFF WAS OPENING AN AG636 ARTEGRAFT FOR A CASE AND THEY SAID IT WAS LEAKING AND THE BALLOON DID NOT INFLATE. FROM MY UNDERSTANDING IT WAS NOT IMPLANTED IN THE PATIENT." NO PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11697296 ↗
• MalfunctionApr 24, 2020Material Puncture/Hole; Material Puncture/Hole

  ARTEGRAFT INC. RECEIVED AN EMAIL COMMUNICATION FROM AN AUTHORIZED DISTRIBUTOR THAT AN ARTEGRAFT (COLLAGEN VASCULAR GRAFT) WAS IDENTIFIED PRIOR TO IMPLANT AS HAVING A "HOLE". IT WAS ALSO NOTED THAT THE GRAFT "SEEMED THINNER THAN NORMAL". THE SURGEON WAS ABLE TO REPAIR THE GRAFT HOLE WITH SUTURE BUT SUBSEQUENTLY TRIMMED, AND DISPOSED OF THAT PORTION OF THE GRAFT; THE REMAINING GRAFT LENGTH (LOT: 19L318-027) WAS SUCCESSFULLY IMPLANTED. NO PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9998316 ↗
• MalfunctionOct 22, 2018Leak/Splash; Leak/Splash

  ARTEGRAFT, INC. RECEIVED AN ELECTRONIC IMPLANT USAGE CARD WITH A NOTE STATING "GRAFT IS DEFECTIVE AND WILL BE PICKED UP BY VENDOR FOR EVALUATION". ADDITIONAL INFORMATION WAS RECEIVED FROM AN APPROVED DISTRIBUTOR REPRESENTATIVE ON BEHALF OF A VASCULAR SURGEON (DR. (B)(6)) EXPLAINING THAT THE GRAFT HAD LEAKED DURING THE PRE-IMPLANT PRESSURE TEST PER THE CORRESPONDING ARTEGRAFT, INC. IFU. THE SURGEON DID NOT IMPLANT THE GRAFT (17M381-020). NO PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7990809 ↗
• InjuryFeb 7, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ARTEGRAFT, INC. RECEIVED AN EMAIL FROM AN APPROVED DISTRIBUTOR REPRESENTATIVE ON BEHALF OF A VASCULAR SURGEON (DR. (B)(6)) STATING THAT HE RECENTLY HAD 2 PATIENTS THAT ACQUIRED INFECTIONS ROUGHLY 2 WEEKS POST-OP ARTEGRAFT (COLLAGEN VASCULAR GRAFT) IMPLANT FOR PERIPHERAL USE. THIS FILE WILL CAPTURE PATIENT 2 OF 2. ON (B)(6) 2017 THE PATIENT HAD AN ARTEGRAFT IMPLANTED FOR FEMORAL POPLITEAL AT THE RIGHT KNEE. THE PATIENT PRESENTED TO THE ER AT (B)(6) ON (B)(6) 2017 WITH INFECTION, FEVER, SEVERELY SEPTIC AND TESTED POSITIVE FOR MULTIPLE INFECTIONS AT DISTAL/PROXIMAL END OF GRAFT. AFTER 2 DAYS ((B)(6) 2017) THE PATIENT WAS TRANSFERRED TO (B)(6) TO DR. (B)(6) FOR SURGERY. ON (B)(6) 2017 DR. (B)(6) DICTATION SAYS: INCISION, DRAINAGE AND WASHOUT OF RIGHT LOWER EXTREMITY THIGH AND GROIN. APPLIED WOUND VAC. ANTIBIOTIC BEAD PLACEMENT RIGHT THIGH AND GROIN. RIGHT THIGH MUSCLE FLAP COVERAGE OF GRAFT. INFECTION SPECIES WAS NOT NOTED. NO INFORMATION WAS PROVIDED REGARDING STATUS OF GRAFT AFTER THE PATIENT WAS TRANSFERRED BACK TO THE NURSING HOME. NO NOTES OF GRAFT FAILURE. PATIENT IS REPORTEDLY BACK AT THE HOSPITAL FOR "OTHER REASONS".

  Patient problems: Post Operative Wound Infection

  MAUDE report 7247267 ↗
• InjuryFeb 7, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ARTEGRAFT, INC. RECEIVED AN EMAIL FROM AN APPROVED DISTRIBUTOR REPRESENTATIVE ON BEHALF OF A VASCULAR SURGEON (DR. (B)(6)) STATING THAT HE RECENTLY HAD 2 PATIENTS THAT ACQUIRED INFECTIONS ROUGHLY 2 WEEKS POST-OP ARTEGRAFT (COLLAGEN VASCULAR GRAFT) IMPLANT FOR PERIPHERAL USE. THIS FILE WILL CAPTURE PATIENT 1 OF 2. ON (B)(6) 2017 THE PATIENT HAD FEMORODISTAL BYPASS SURGERY WITH TWO 5MM ARTEGRAFTS. THE BYPASS "WENT DOWN" AND THE PATIENT ENDED UP IN ANOTHER FACILITY BEFORE COMING BACK TO DR. (B)(6). WHEN THE PATIENT PRESENTED TO HIM ROUGHLY 2 WEEKS POST-OP, SHE HAD PSEUDOMONAS. THE SURGEON MENTIONED THAT THE GRAFT "DISSOLVED" IN A PORTION WHERE IT WAS INFECTED AND HAD A "BIG HOLE" IN IT. THE PATIENT REPORTEDLY EXPIRED AND IT WAS STATED THAT IT WAS "NOT DUE TO THE ARTEGRAFT".

  Patient problems: Hematoma; Post Operative Wound Infection

  MAUDE report 7247266 ↗
• InjuryFeb 7, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ARTEGRAFT, INC. RECEIVED AN EMAIL FROM AN APPROVED DISTRIBUTOR REPRESENTATIVE ON BEHALF OF A VASCULAR SURGEON ((B)(6)) STATING THAT HE RECENTLY HAD 2 PATIENTS THAT ACQUIRED INFECTIONS ROUGHLY 2 WEEKS POST-OP ARTEGRAFT (COLLAGEN VASCULAR GRAFT) IMPLANT FOR PERIPHERAL USE. THIS FILE WILL CAPTURE PATIENT 1 OF 2. ON (B)(6) 2017 THE PATIENT HAD FEMORODISTAL BYPASS SURGERY WITH TWO 5 MM ARTEGRAFTS. THE BYPASS "WENT DOWN" AND THE PATIENT ENDED UP IN ANOTHER FACILITY BEFORE COMING BACK TO DR. WEISS. WHEN THE PATIENT PRESENTED TO HIM ROUGHLY 2 WEEKS POST-OP SHE HAD PSEUDOMONAS. THE SURGEON MENTIONED THAT THE GRAFT "DISSOLVED" IN A PORTION WHERE IT WAS INFECTED AND HAD A "BIG HOLE" IN IT. THE PATIENT REPORTEDLY EXPIRED AND IT WAS STATED THAT IT WAS "NOT DUE TO THE ARTEGRAFT".

  Patient problems: Hematoma; Post Operative Wound Infection

  MAUDE report 7247260 ↗
• MalfunctionJan 11, 2018Physical Property Issue; Physical Property Issue

  RECEIVED A PHONE CALL FROM AN APPROVED DISTRIBUTOR STATING THAT DURING THE IMPLANT OF THE ARTEGRAFT (COLLAGEN VASCULAR GRAFT) A SURGEON HAD "DIFFICULTY SUTURING". IN FOLLOW-UP COMMUNICATIONS IT WAS CLARIFIED THAT THE GRAFT WAS "BLEEDING AFTER EVERY STITCH" EVEN USING 7-0 SIZE SUTURE. THE SURGEON STATED THAT THE GRAFT THICKNESS WAS NOT THE ACCEPTABLE MEASUREMENT; ONE END WAS OK, BUT THE OTHER END WAS "WAY TOO THIN". "THIS CAUSED MAJOR SUTURE HOLE BLEEDING AFTER EVERY STICH." THE SURGEON "OVERSEWED AND THE BLEEDING WAS CONTROLLED". THE IMPLANT WAS COMPLETED AND THE PATIENT WAS STABLE. THE SURGEON HAS SEEN THE PATIENT IN THE OFFICE AFTER THE IMPLANT AND THE "GRAFT IS FUNCTIONING FINE".

  Patient problems: Blood Loss

  MAUDE report 7182202 ↗
• MalfunctionOct 17, 2017Leak/Splash; Leak/Splash

  ARTEGRAFT INC. RECEIVED AN EMAIL COMMUNICATION FROM AN AUTHORIZED DISTRIBUTOR THAT AN ARTEGRAFT (COLLAGEN VASCULAR GRAFT) WAS IDENTIFIED AS LEAKING DURING THE PRE-IMPLANT PRESSURE TESTING PER THE CORRESPONDING ARTEGRAFT IFU. THE SURGEON NOTED THAT THE GRAFT APPEARED TO HAVE A SMALL 1 MM HOLE IN IT AND WAS LEAKING IN THE MIDDLE OF THE GRAFT, NOT NEAR A BRANCH. THE SURGEON WAS ABLE TO REPAIR THE GRAFT HOLE WITH 6.0 PROLENE SUTURE AND THE GRAFT (LOT: 17A008-009) WAS SUCCESSFULLY IMPLANTED. NO PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6955649 ↗

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