VASCU-GUARD Peripheral Vascular Patch VG0108NRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00085412530895), received between Aug 22, 2016 and Dec 5, 2024 — classified as 1 death, 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A VASCU-GUARD PERIPHERAL VASCULAR PATCH HAD A FLOATING WHITE SUBSTANCE ON THE SURFACE OF THE LIQUID. THIS WAS FOUND WHEN THE NURSE REMOVED THE JAR LID. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20858252 ↗
• MalfunctionJan 26, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FUNGUS OR HAIR WAS OBSERVED ON A VASCU-GUARD APEX 0.8 X 8. THE ISSUE WAS IDENTIFIED DURING SETUP AND PREPARATION. THE SEAL WAS POPPED OPEN, BUT THE TISSUE WAS NEVER REMOVED FROM THE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16247212 ↗
• MalfunctionJan 4, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PARTICULATE MATTER (PM) WAS FOUND ON A VASCU-GUARD PERIPHERAL VASCULAR PATCH. THE PM WAS FURTHER DESCRIBED AS, ¿FLUFF ON THE PRODUCT¿. THE PM WAS DISCOVERED DURING SETUP PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095056 ↗
• MalfunctionJan 7, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A VASCU-GUARD APEX 0.8 X 8 HAD PARTICULATE MATTER. THE EVENT WAS FURTHER DESCRIBED AS A FLUFF WAS FOUND ON THE PRODUCT. THIS ISSUE WAS IDENTIFIED DURING SETUP AND PREPARATION PRIOR TO PATIENT USE. AS A RESULT, THE DOCTOR DID NOT USE THE PERIPHERAL VASCULAR PATCH. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13196923 ↗
• MalfunctionDec 1, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A HAIR WAS FOUND IN A VASCU-GUARD PRODUCT. THIS WAS IDENTIFIED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12910163 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A CAROTID ARTERY ENDARTERECTOMY SURGERY IN WHICH VASCU-GUARD PATCHES WERE USED. FOLLOWING SURGERY, THE PATIENT WAS TRANSFERRED TO THE CARDIAC CARE UNIT (CCU) WITH NO SIGNS OF HEMATOMA AND A JP DRAIN IN PLACE. APPROXIMATELY FIVE HOURS LATER, THE PATIENT EXPERIENCED BLEEDING AND PRESENTED WITH A DEVIATED TRACHEA, NO STRIDOR WAS NOTED. IT WAS REPORTED 10 MINUTES LATER, THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM AND WAS INTUBATED. FOLLOWING INTUBATION, ¿VERY LARGE AMOUNT OF BLOOD CLOTS¿ WERE EVACUATED, AND AFTER THE CAROTID ARTERY WAS VISIBLE, THE DOCTOR NOTED THAT A PORTION OF THE VASCU-GUARD WAS ¿FRAYED¿ OR ¿SOMEHOW DEGRADED¿. THE PHYSICIAN WAS NOT ABLE TO RECOVER PIECES OF THE GRAFT AREA. A SECOND VASCU-GUARD PATCH WAS PUT IN PLACE TO RE-ENFORCE THE ORIGINAL PATCH GRAFT SITE, NO ISSUES WERE NOTED. THE PATIENT REMAINED INTUBATED AND TRANSFERRED BACK TO CCU. ADDITIONAL TREATMENT OR INTERVENTIONS WERE NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hematoma

  MAUDE report 11113445 ↗
• MalfunctionJul 30, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A WHITE PARTICULATE MATTER WAS FOUND FLOATING INSIDE THE PACKAGING OF A VASCU-GUARD PATCH. THIS WAS IDENTIFIED DURING SETUP AND PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10344231 ↗
• MalfunctionFeb 21, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT HAIR WAS OBSERVED ON A VASCU-GUARD PATCH. THIS ISSUE WAS IDENTIFIED DURING SETUP AND PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9742341 ↗
• MalfunctionJan 31, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. IT WAS REPORTED THAT THERE WAS A BLACK SPOT ON THE END OF A VASCU-GUARD PATCH. THIS WAS NOTED UPON OPENING THE PACK BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8293039 ↗
• DeathJun 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT EXPERIENCED AN ARTERIAL HEMORRHAGE, A NECK HEMATOMA, TRACHEAL COMPRESSION LEADING TO HYPOXIA AND SUBSEQUENT DEATH AFTER UNDERGOING A LEFT CAROTID ENDARTERECTOMY (CEA) IN WHICH A VASCU-GUARD PATCH WAS USED. THERE WERE NO ISSUES NOTED WITH THE PATCH OR WITH BLEEDING INTRAOPERATIVELY. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. APPROXIMATELY ONE AND ONE HALF HOURS AFTER SURGERY, THE PATIENT PASSED AWAY. IT WAS REPORTED THE PATIENT EXPERIENCED A LARGE HEMATOMA THAT WAS COMPRESSING THE TRACHEA CONSISTENT WITH A SUTURE LINE BLOWOUT. PER THE DEATH CERTIFICATE THE PRIMARY CAUSE OF DEATH WAS HYPOXIA, WITH SECONDARY CAUSES LISTED AS COMPRESSION FROM NECK HEMATOMA AND ARTERIAL HEMORRHAGE FOLLOWING CEA. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Hypoxia

  MAUDE report 7560898 ↗
• InjuryAug 22, 2016Positioning Problem

  BAXTER VASCUGUARD PERIPHERAL PATCH WAS APPLIED DURING AN ENDARTERECTOMY ON (B)(6) 2016. ON (B)(6) 2016, THE PT RETURNED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF NECK SWELLING AT THE SURGICAL SITE. A SURGICAL REVISION WAS PERFORMED. THE PATCH WAS NOT INTACT.

  Patient problems: Swelling

  MAUDE report 5903577 ↗