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AlboSure Vascular Patch AP10100RRecalls & reported problems

Lemaitre Vascular, Inc. · AlboSure Vascular Patch 1x 10 cm · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840663104802), received between Aug 10, 2018 and Aug 10, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Material Puncture/Hole” (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

Device problems

  • Material Puncture/Hole1

Patient problems

  • No Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

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

    A HOLE WAS DETECTED IN AN ALBOSURE PATCH DURING CAROTID ANGIOPLASTY. THE HOLE WAS SEWED USING A 6-0 SUTURE. THIS IS REPORT 1 OF 2. WE HAVE ALSO SUBMITTED ANOTHER COMPLAINT RELATED TO A SIMILAR INCIDENT THAT OCCURRED WITH ALBOSURE PATCH ( LOT# 186578 SERIAL (B)(4)) MFR REPORT # 1220948-2018-00056 REPORTED TO US BY THE SAME SURGEON FROM THE SAME HOSPITAL.

    Patient problems: No Information

    MAUDE report 7773598 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.