XenoSure Biologic Patch e0.8P8Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00840663106295), received between Jan 18, 2018 and Feb 5, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryJan 18, 2018Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A RIGHT CAROTID ENDARTERECTOMY WITH PATCH ANGIOPLASTY ON (B)(6) 2017. PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2017 WITH PURULENT DRAINAGE, DIZZINESS AND PAIN AT THE SITE OF INCISION. PATIENT WAS THEN READMITTED TO THE HOSPITAL ON (B)(6) 2017 FOR WOUND IRRIGATION AND DRAINAGE OF A SUPERFICIAL ABSCESS OF THE RIGHT NECK WOUND. TWO DAYS POST-OPERATION, PATIENT STILL COMPLAINED OF A NECK PAIN, DISCOMFORT, SWELLING, REDNESS, DIZZINESS AND PAIN AT THE SITE.

  Patient problems: Abscess; Discomfort; Dizziness; Erythema; Neck Pain; Pain; Purulent Discharge; Swelling

  MAUDE report 7204770 ↗
• InjuryJan 18, 2018Insufficient Device Problem Information

  PATIENT UNDERWENT A RIGHT CAROTID ENDARTERECTOMY WITH PATCH ANGIOPLASTY ON (B)(6) 2017. DEEP INCISIONAL SSI WAS DETECTED WITH FEVER CHILLS AND INCREASED SWELLING OF RIGHT SIDE OF THE NECK. PATIENT WAS RE-ADMITTED TO THE HOSPITAL ON (B)(6) 2017 FOR INCISION AND DRAINAGE.

  Patient problems: Chills; Fever; Swelling; Unspecified Infection

  MAUDE report 7204769 ↗
• InjuryJan 18, 2018Insufficient Device Problem Information

  PATIENT HAD A LEFT CAROTID ENDARTERECTOMY WITH PATCH ANGIOPLASTY ON (B)(6) 2017. PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2017 WITH SWELLING, REDNESS AND PAIN OVER THE LEFT NECK. INFECTION HAD EXTENDED DEEP INTO THE CAROTID SHEATH AREA. DEEP INCISIONAL SURGICAL SITE INFECTION WAS OBSERVED.

  Patient problems: Erythema; Pain; Post Operative Wound Infection; Swelling

  MAUDE report 7204768 ↗
• InjuryJan 18, 2018Insufficient Device Problem Information

  PATIENT UNDERWENT LEFT CAROTID ENDARTERECTOMY WITH PATCH ANGIOPLASTY ON (B)(6) 2017. PATIENT COMPLAINED ABOUT LUMP ON THE SIDE OF THE NECK AT THE SITE OF PATCH IMPLANT AND RETURNED TO THE HOSPITAL ON (B)(6) 2017. ORAL ANTIBIOTICS WAS PRESCRIBED AND PATIENT WAS SENT HOME. DURING FOLLOW-UP ON (B)(6) 2017, SUPERFICIAL ABSCESS WAS OBSERVED. INCISION AND DRAINAGE WAS PERFORMED. BOIL WAS OBSERVED ON DISTAL INCISION ON THE DAY OF I&D. SMALL 1.5 CM X 1.5 CM FLUID WAS COLLECTED BETWEEN THE TWO INCISIONS.

  Patient problems: Abscess; Fluid Discharge; Swelling

  MAUDE report 7204767 ↗