PTFE Polymer Pledgets 88868677-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521104617), received between Aug 14, 2019 and Aug 14, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 14, 2019Migration or Expulsion of Device; Detachment of Device or Device Component; Migration or Expulsion of Device; Detachment of Device or Device Component

  ACCORDING TO THE SURVEY PERFORMED WHICH COVERS THE LAST 12 MONTHS FOR THE ADVERSE EVENT REACTION USING THE SUTURE, ONE SEPARATION FROM SUTURE MATERIAL AFTER VASCULAR SUTURE, ONE MILD INFECTION OR ABSCESS FORMATION, ONE PLEDGET MIGRATION, AND ONE MILD ACUTE INFLAMMATORY REACTION WERE EXPERIENCED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 8895683 ↗
• InjuryAug 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE SURVEY CONDUCTED FOR WOUND SUTURE, A PLEDGET MIGRATION WAS OBSERVED ON 2 PATIENTS - WHICH WAS RELATED TO LOOSE STITCHES AND BADLY POSITIONED PLEDGETS.

  Patient problems: No Code Available

  MAUDE report 8895494 ↗