XenoSure Biologic PatchRecalls & reported problems across all models

We found 7 models of XenoSure Biologic Patch by Lemaitre Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Dec 8, 2017 and Apr 28, 2026 — classified as 22 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (8 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

Most reported XenoSure Biologic Patch problems

XenoSure Biologic Patch models

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

• XenoSure Biologic Patch e1P6

  Mesh, Surgical
  10 reports
• XenoSure Biologic Patch e0.8P8

  Mesh, Surgical
  7 reports
• XenoSure Biologic Patch 0.6BV8

  Mesh, Surgical
  5 reports
• XenoSure Biologic Patch e2P9

  Mesh, Surgical
  1 report
• XenoSure Biologic Patch e4P4

  Mesh, Surgical
  1 report
• XenoSure Biologic Patch e10P16

  Mesh, Surgical
  1 report
• XenoSure Biologic Patch e6P8

  Mesh, Surgical
  1 report

Recent XenoSure Biologic Patch adverse event reports

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

• InjuryApr 28, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT THE XENOSURE TESTED POSITIVE ON CULTURE FOR CUTIBACTERIUM ACNES. THE CAUSE WAS ATTRIBUTED TO POSSIBLE OR CONTAMINATION. THE PRODUCT WAS IMPLANTED. IT IS NOT KNOWN WHAT ACTIONS, IF ANY, WERE TAKEN TO TREAT OR RESOLVE THE INFECTION, AS SPECIFIC DETAILS OF THE EVENT WERE NOT PROVIDED. NO OTHER PATIENT INJURY OR COMPLICATIONS WAS REPORTED.

  Patient problems: Medical device site infection

  MAUDE report 25016969 ↗
• InjuryFeb 5, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATHOLOGY EXAMINATION OF THE PATIENT'S CAROTID PLAQUE TISSUE REVEALED ORGANISMS CONSISTENT WITH ASPERGILLUS. INFECTION CONTROL INDICATED THAT THIS FINDING MAY BE ASSOCIATED WITH THE BOVINE PATCH USED DURING A PRIOR CAROTID SURGERY. NO OTHER COMPLICATIONS OR PATIENT INJURY WAS REPORTED.

  Patient problems: Medical device site infection

  MAUDE report 24266852 ↗
• InjuryMay 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A STAPH INFECTION FOLLOWING IMPLANTATION OF A 2X9 XENOSURE BIOLOGIC PATCH. ORIGINAL PROCEDURE WAS ON (B)(6) 2025 FOR A FEMORAL ENDARTERECTOMY WITH PATCH ANGIOPLASTY AND STENTING. THE PATIENT RETURNED ON (B)(6) 2025 FOR AN INCISION AND DRAINAGE OF THE WOUND. THE PATIENT WAS DISCHARGED HOME WITH A WOUND VAC AND THE WOUND IS IMPROVING. THE PATIENT IS STILL ON ANTIBIOTICS. THE PATCH REMAINS IMPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 22107422 ↗
• MalfunctionMay 6, 2025Contamination; Contamination

  IT WAS REPORTED THAT THE PATCH WAS IMPLANTED DURING A HECTIC CODE PERFUSION CRITICAL LAPAROTOMY (POST KIDNEY TRANSPLANT) WHERE PATIENT PRESENTED IN HEMORRHAGIC SHOCK PRE-OP. A SAMPLE OF THE GRAFT WAS SENT AFTER BEING OPENED (AND ADMITTEDLY HANDLED BY MULTIPLE PEOPLE; IN CONTACT WITH PATIENT AND PATIENT CONTAMINATED INSTRUMENTS/GLOVES). SAID SAMPLE CAME BACK POSITIVE FOR CULTURED OF CANDIDA FUNGUS. GRAFT WAS ALREADY IMPLANTED. NO UNUSUAL HARM OR INJURY HAS BEEN CAUSED BY THE INCIDENT AND PATIENT HAS SINCE BEEN DISCHARGED.

  Patient problems: Bacterial Infection

  MAUDE report 21968530 ↗
• InjuryMar 28, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT HAD A CAROTID ENDARTERECTOMY WITH PATCH ANGIOPLASTY USING THE XENOSURE PATCH. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2025. THE PATIENT CAME BACK TO THE HOSPITAL WITH AN INFECTION ON (B)(6) 2025. ON (B)(6) 2025 THE INFECTION WAS REMOVED AND THE INTERVENTION WAS REPAIRED WITH THE PATIENT'S GREAT SAPHENOUS VEIN. THE VASCULAR COORDINATOR DID NOT KNOW THE EXACT CAUSE OF THE INFECTION. ADDITIONAL INFORMATION RECEIVED STATES THE CULTURE GREW STREP ANGINOUSUS.

  Patient problems: Medical device site infection

  MAUDE report 21718898 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A CAROTID OPERATION THAT TRIGGERED A POST-OPERATIVE STROKE, WHICH REQUIRED RE-INTERVENTION. THE SURGEON SUSPECTS A POSSIBLE DEVICE FAILURE RELATED TO THE ADHESION OF THE DEVICE OF THE IMPLANTED DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED TO THE PATIENT. ADDITIONAL INFORMATION INCLUDING THE PRECISE IMPLANT DATE, DETAILS OF THE PROCEDURE AND INTERVENTION WERE REQUESTED. ADDITIONAL INFORMATION WAS ALSO REQUESTED RELATED TO THE ADDITIONAL ISSUES THAT HAVE OCCURRED, BUT NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

  Patient problems: Stroke/CVA

  MAUDE report 21533523 ↗
• InjuryMay 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT POST CAROTID ENDARTERECTOMY WITH XENOSURE PATCH ANGIOPLASTY, THE PATIENT CAME BACK WITH A STAPHYLOCOCCUS INFECTION ORIGINATING FROM THE PATCH SITE. THE INFECTED PATCH WAS REMOVED AND THE PATIENT'S CAROTID WAS REPAIRED WITH APPLICATION OF NATIVE GSV GRAFT.

  Patient problems: Bacterial Infection

  MAUDE report 19322843 ↗
• MalfunctionMay 1, 2024

  OPENED IMPLANT AND FOUND UNEXPECTED CLEAR PLASTIC FLOATING IN THE CONTAINER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220331 ↗
• InjuryApr 10, 2024Compatibility Problem; Compatibility Problem

  THE DISTRIBUTOR WAS INFORMED BY THE CUSTOMER OF OBSTRUCTION CASES AFTER A FEW MONTHS OF XENOSURE IMPLANTATION: THERE HAVE BEEN FOUR CASES IN TOTAL, TWO OF THE SURGERIES WERE PERFORMED IN (B)(6) 2022 AND ANOTHER TWO IN (B)(6) 2023. THE SIZE USED WAS 0.6X0.8. ACCORDING TO OUR SUPPLY DATA, THE PRODUCT IMPLEMENTED IS IN ACCORDANCE WITH THE CODE 0.6BV8. AFTER A FEW MONTHS OF FOLLOW-UP AND UNDER ULTRASOUND, A SMALL OBSTRUCTION COULD BE OBSERVED IN ALL FOUR CASES. AFTER 8 MONTHS THIS OBSTRUCTION HAS INCREASED IN VOLUME, NOT YET BEING A CRITICAL OBSTRUCTION. THE OBSTRUCTION CANNOT BE DEFINED AS A COMMON PLAQUE, ITS TEXTURE IS SMOOTHER, AND ITS SHAPE IS LIKE AN HOURGLASS, AS IF IT WERE AN INFLAMMATORY REACTION. THE SURGEON HAS BEEN USING THIS PRODUCT SINCE 2019 AND HAS NOT HAD ANY CASES OF OBSTRUCTION SO FAR. ACCORDING TO THE INDICATIONS OF THE PATCH, IT IS NOT SPECIFIED ON WHICH SIDE IT IS RECOMMENDED TO IMPLANT THE PATCH, BUT THE SURGEON OBSERVED UNDER A MAGNIFYING GLASS THAT ONE OF THE SIDES IS FLATTER AND THIS IS THE SIDE THAT IMPLANT INWARDS. THE SURGEON IS NOT COMPLETELY CONVINCED THAT THE OBSTRUCTION IS CAUSED BY THE PATCH; HOWEVER, HE WANTED TO CONFIRM BY REQUESTING AN ANSWER FROM L

  Patient problems: Inflammation; Obstruction/Occlusion

  MAUDE report 19085425 ↗
• InjuryApr 10, 2024Compatibility Problem; Compatibility Problem

  THE DISTRIBUTOR WAS INFORMED BY THE CUSTOMER OF OBSTRUCTION CASES AFTER A FEW MONTHS OF XENOSURE IMPLANTATION: THERE HAVE BEEN FOUR CASES IN TOTAL, TWO OF THE SURGERIES WERE PERFORMED IN (B)(6) 2022 AND ANOTHER TWO IN (B)(6) 2023. THE SIZE USED WAS 0.6X0.8. ACCORDING TO OUR SUPPLY DATA, THE PRODUCT IMPLEMENTED IS IN ACCORDANCE WITH THE CODE 0.6BV8. AFTER A FEW MONTHS OF FOLLOW-UP AND UNDER ULTRASOUND, A SMALL OBSTRUCTION COULD BE OBSERVED IN ALL FOUR CASES. AFTER 8 MONTHS THIS OBSTRUCTION HAS INCREASED IN VOLUME, NOT YET BEING A CRITICAL OBSTRUCTION. THE OBSTRUCTION CANNOT BE DEFINED AS A COMMON PLAQUE, ITS TEXTURE IS SMOOTHER, AND ITS SHAPE IS LIKE AN HOURGLASS, AS IF IT WERE AN INFLAMMATORY REACTION. THE SURGEON HAS BEEN USING THIS PRODUCT SINCE 2019 AND HAS NOT HAD ANY CASES OF OBSTRUCTION SO FAR. ACCORDING TO THE INDICATIONS OF THE PATCH, IT IS NOT SPECIFIED ON WHICH SIDE IT IS RECOMMENDED TO IMPLANT THE PATCH, BUT THE SURGEON OBSERVED UNDER A MAGNIFYING GLASS THAT ONE OF THE SIDES IS FLATTER AND THIS IS THE SIDE THAT IMPLANT INWARDS. THE SURGEON IS NOT COMPLETELY CONVINCED THAT THE OBSTRUCTION IS CAUSED BY THE PATCH; HOWEVER, HE WANTED TO CONFIRM BY REQUESTING AN ANSWER FROM L

  Patient problems: Inflammation; Obstruction/Occlusion

  MAUDE report 19085424 ↗
• InjuryApr 10, 2024Compatibility Problem; Compatibility Problem

  THE DISTRIBUTOR WAS INFORMED BY THE CUSTOMER OF OBSTRUCTION CASES AFTER A FEW MONTHS OF XENOSURE IMPLANTATION: THERE HAVE BEEN FOUR CASES IN TOTAL, TWO OF THE SURGERIES WERE PERFORMED IN (B)(6) 2022 AND ANOTHER TWO IN (B)(6) 2023. THE SIZE USED WAS 0.6X0.8. ACCORDING TO OUR SUPPLY DATA, THE PRODUCT IMPLEMENTED IS IN ACCORDANCE WITH THE CODE 0.6BV8. AFTER A FEW MONTHS OF FOLLOW-UP AND UNDER ULTRASOUND, A SMALL OBSTRUCTION COULD BE OBSERVED IN ALL FOUR CASES. AFTER 8 MONTHS THIS OBSTRUCTION HAS INCREASED IN VOLUME, NOT YET BEING A CRITICAL OBSTRUCTION. THE OBSTRUCTION CANNOT BE DEFINED AS A COMMON PLAQUE, ITS TEXTURE IS SMOOTHER, AND ITS SHAPE IS LIKE AN HOURGLASS, AS IF IT WERE AN INFLAMMATORY REACTION. THE SURGEON HAS BEEN USING THIS PRODUCT SINCE 2019 AND HAS NOT HAD ANY CASES OF OBSTRUCTION SO FAR. ACCORDING TO THE INDICATIONS OF THE PATCH, IT IS NOT SPECIFIED ON WHICH SIDE IT IS RECOMMENDED TO IMPLANT THE PATCH, BUT THE SURGEON OBSERVED UNDER A MAGNIFYING GLASS THAT ONE OF THE SIDES IS FLATTER AND THIS IS THE SIDE THAT IMPLANT INWARDS. THE SURGEON IS NOT COMPLETELY CONVINCED THAT THE OBSTRUCTION IS CAUSED BY THE PATCH; HOWEVER, HE WANTED TO CONFIRM BY REQUESTING AN ANSWER FROM L

  Patient problems: Inflammation; Obstruction/Occlusion

  MAUDE report 19085421 ↗
• InjuryApr 10, 2024Compatibility Problem; Compatibility Problem

  THE DISTRIBUTOR WAS INFORMED BY THE CUSTOMER OF OBSTRUCTION CASES AFTER A FEW MONTHS OF XENOSURE IMPLANTATION: THERE HAVE BEEN FOUR CASES IN TOTAL, TWO OF THE SURGERIES WERE PERFORMED IN (B)(6) 2022 AND ANOTHER TWO IN (B)(6) 2023. THE SIZE USED WAS 0.6X0.8. ACCORDING TO OUR SUPPLY DATA, THE PRODUCT IMPLEMENTED IS IN ACCORDANCE WITH THE CODE 0.6BV8. AFTER A FEW MONTHS OF FOLLOW-UP AND UNDER ULTRASOUND, A SMALL OBSTRUCTION COULD BE OBSERVED IN ALL FOUR CASES. AFTER 8 MONTHS THIS OBSTRUCTION HAS INCREASED IN VOLUME, NOT YET BEING A CRITICAL OBSTRUCTION. THE OBSTRUCTION CANNOT BE DEFINED AS A COMMON PLAQUE, ITS TEXTURE IS SMOOTHER, AND ITS SHAPE IS LIKE AN HOURGLASS, AS IF IT WERE AN INFLAMMATORY REACTION. THE SURGEON HAS BEEN USING THIS PRODUCT SINCE 2019 AND HAS NOT HAD ANY CASES OF OBSTRUCTION SO FAR. ACCORDING TO THE INDICATIONS OF THE PATCH, IT IS NOT SPECIFIED ON WHICH SIDE IT IS RECOMMENDED TO IMPLANT THE PATCH, BUT THE SURGEON OBSERVED UNDER A MAGNIFYING GLASS THAT ONE OF THE SIDES IS FLATTER AND THIS IS THE SIDE THAT IMPLANT INWARDS. THE SURGEON IS NOT COMPLETELY CONVINCED THAT THE OBSTRUCTION IS CAUSED BY THE PATCH; HOWEVER, HE WANTED TO CONFIRM BY REQUESTING AN ANSWER FROM L

  Patient problems: Inflammation; Obstruction/Occlusion

  MAUDE report 19085420 ↗
• MalfunctionOct 13, 2023Material Discolored; Fluid/Blood Leak; Material Too Rigid or Stiff; Material Discolored; Fluid/Blood Leak; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE XENOSURE BIOLOGIC PATCH THAT WAS USED DURING A CAROTID ENDARTERECTOMY PROCEDURE WAS DIFFERENT IN COLORING, TEXTURE AND FELT DIFFERENT (WOULDN'T CONTOUR, FELT HARD/LEATHERY). THE SURGEON CHOSE TO USE THE PATCH AND NOT REPLACE THE DEVICE WITH ANOTHER ONE. IT WAS REPORTED THAT AS A RESULT OF THE PATCH BEING STIFFER AND FEELING DIFFERENT, THE DEVICE TOOK LONGER TO SEW THAN NORMAL WHICH RESULTED IN LEAKAGE FROM THE SITE DURING THE PROCEDURE. ALTHOUGH THE PROCEDURE WAS DELAYED, THE SURGEON WAS SUCCESSFUL IN COMPLETING THE PROCEDURE USING THE DEVICE. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17930588 ↗
• InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING LITERATURE REVIEW THE ARTICLE INDICATED THAT ONE LIMB (2%) WITHOUT POSTOPERATIVE WOUND COMPLICATIONS REQUIRED ADDITIONAL TREATMENT DUE TO ACUTE BLEEDING DURING A STUDY TITLED "CLINICAL OUTCOMES OF COMMON FEMORAL THROMBOENDARTERECTOMY WITH BOVINE PERICARDIUM PATCH ANGIOPLASTY".

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17698111 ↗
• InjuryJun 24, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  PATIENT HAD A CAROTID ENDARTERECTOMY WITH PATCH DONE ON 2020. SHE WAS PRESENTED IN 2022 WITH AN INFECTED PATCH REQUIRING SURGICAL INTERVENTION. FDA NOTIFIED THIS INCIDENT TO LEMAITRE ON 5/27/2022. FDA PROVIDED LEMAITRE WITH A COPY OF VOLUNTARY MEDWATCH REPORT# MW5109514.

  Patient problems: Unspecified Infection

  MAUDE report 14799415 ↗

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