AlboSure Vascular Patch AP08075TRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840663104604), received between Nov 4, 2016 and Aug 10, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Hole In Material” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2018Material Puncture/Hole; Material Puncture/Hole

  TWO HOLES WERE DETECTED IN AN ALBOSURE PATCH DURING CAROTID ANGIOPLASTY. THIS IS REPORT 2 OF 2. WE HAVE ALSO SUBMITTED ANOTHER COMPLAINT RELATED TO A SIMILAR INCIDENT THAT OCCURRED WITH ALBOSURE PATCH ( LOT# 204574 SERIAL (B)(4)) MFG REPORT# 1220948-2018-00055 REPORTED TO US BY THE SAME SURGEON FROM THE SAME HOSPITAL.

  Patient problems: No Information

  MAUDE report 7773601 ↗
• MalfunctionNov 4, 2016Hole In Material; Physical Property Issue; Hole In Material; Physical Property Issue

  AT THE END OF THE OPERATION, WHEN THE SURGEON REMOVED THE CLAMP THERE WAS A HOLE IN THE MIDDLE OF THE PATCH. SO HE DECIDED TO EXPLANT THE PATCH AND PUT AN ANOTHER PATCH THERE.

  Patient problems: No Code Available

  MAUDE report 6079251 ↗