XenoSure Biologic Patch 0.6BV8Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00840663106745), received between Apr 10, 2024 and Mar 6, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Compatibility Problem” (4 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, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗