XenoSure Biologic Patch e1P6Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00840663106288), received between Dec 8, 2017 and Mar 28, 2025 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A CAROTID ENDARTERECTOMY WITH PATCH DONE ON (B)(6) 2020. SHE PRESENTED IN (B)(6) 2022 WITH AN INFECTION THAT REQUIRED SURGICAL INTERVENTION. CULTURE OF EXPLANTED PATCH SHOWED INFECTION.

  Patient problems: Bacterial Infection

  MAUDE report 14197397 ↗
• InjuryNov 25, 2020Insufficient Device Problem Information

  ON (B)(6) 2020, SURGEON INQUIRED SALES REP. IF HE HAS EVER SEEN OR IF THERE IS ANY DOCUMENTATION OF THROMBOSIS OF FEMORAL ARTERY AFTER PATCH PLACEMENT AND ENDARTERECTOMY.

  Patient problems: Stenosis; Thrombosis/Thrombus

  MAUDE report 10899816 ↗
• InjuryFeb 21, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A ROUTINE SALES CALL, SURGEON MENTIONED A SERIES OF 3 CAROTID ENTARTERECTOMY PATIENTS WHO WERE READMITTED DUE TO BLOOD CLOTS. THIS IS REPORT 2 OF 3 OF THAT SERIES.

  Patient problems: Thrombosis

  MAUDE report 8357852 ↗
• InjuryFeb 21, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A ROUTINE SALES CALL, SURGEON MENTIONED A SERIES OF 3 CAROTID ENDARTERECTOMY. PATIENTS WHO WERE READMITTED DUE TO BLOOD CLOTS. THIS IS REPORT 3 OF 3 OF THAT SERIES.

  Patient problems: Thrombosis

  MAUDE report 8357850 ↗
• InjuryFeb 21, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A ROUTINE SALES CALL, SURGEON MENTIONED A SERIES OF 3 CAROTID ENDARTERECTOMY PATIENTS WHO WERE READMITTED DUE TO BLOOD CLOTS. THIS IS REPORT 1 OF 3 OF THAT SERIES.

  Patient problems: Thrombosis

  MAUDE report 8357848 ↗
• InjuryDec 1, 2018Material Integrity Problem; Material Integrity Problem

  ON (B)(6) 2018, PATIENT UNDERWENT RIGHT CAROTID ENDARTERECTOMY FOLLOWED BY AN ANGIOPLASTY CLOSURE OF THE CAROTID ARTERY USING A XENOSURE BIOLOGIC PATCH CATALOG# E1P6 LOT# XBU3083. ON (B)(6) 2018, THE PATIENT RETURNED TO THE HOSPITAL WITH A MODERATE SIZED LOCALIZED HEMATOMA IN THE SUPERIOR ASPECT OF THE RIGHT NECK INCISION. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) OF THE NECK PERFORMED AT THE FACILITY DIAGNOSED A PSEUDOANEURYSM WITH AN ACTIVE BLEEDING OF THE CAROTID ARTERY AT THE IMPLANTED PATCH SITE .

  Patient problems: Hematoma

  MAUDE report 8122025 ↗
• MalfunctionDec 8, 2017Delamination; Delamination

  XENOSURE PATCH FRAYED AFTER BEING SUTURED IN THE PATIENT. SO, THE PATCH WAS EXPLANTED AND REPLACED WITH AN ANOTHER PATCH.

  Patient problems: No Information

  MAUDE report 7100932 ↗