Skip to content

PTFE Polymer Pledgets 88868679-01Recalls & reported problems

Covidien LP · Nonabsorbable Pre-punched Pledgets,5x Soft PTFE Pledgets 9.5x4.8x1.5mm · 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 10884521104631), received between Aug 14, 2019 and Aug 14, 2019 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Inflammation1

Recent adverse event reports

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

  • InjuryAug 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ACCORDING TO THE SURVEY PERFORMED WHICH COVERS THE LAST 12 MONTHS FOR THE ADVERSE EVENT REACTION USING THE SUTURE, ONE MILD ACUTE INFLAMMATORY REACTION WAS EXPERIENCED.

    Patient problems: Inflammation

    MAUDE report 8895444 ↗

Other PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE devices

All PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE devices →

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