PTFE Polymer Pledgets 88868675-01Recalls & reported problems
Covidien LP · Nonabsorbable Pre-punched Pledgets,10x Firm PTFE Pledgets 3x3x1.5mm · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521103184), received between Aug 14, 2019 and May 1, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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.
Reports received per month
Most reported problems
Device problems
- Migration or Expulsion of Device1
- Unraveled Material1
Patient problems
- Inflammation1
- Tissue Breakdown1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 1, 2025Unraveled Material; Unraveled Material
ACCORDING TO THE REPORTER, DURING A CLINICAL STUDY, THE USER IDENTIFIED A PARAVALVULAR LEAK WHILE USING THE DEVICE.
Patient problems: Tissue Breakdown
MAUDE report 21945363 ↗InjuryAug 14, 2019Migration or Expulsion of Device; Migration or Expulsion of Device
ACCORDING TO THE SURVEY PERFORMED WHICH COVERS THE LAST 12 MONTHS FOR THE ADVERSE EVENT REACTION USING THE 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 8895657 ↗
Other PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE devices
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- SJM™ C0914St. Jude Medical, Inc. · PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE1 recall0 reports
- Supple Peri-Guard PC0814SNSynovis Life Technologies, Inc. · PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE1 recall0 reports
- Peri-Guard PC0404NSynovis Life Technologies, Inc. · PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE1 recall0 reports
- Bard® PTFE Felt Pledgets 007963Bard Peripheral Vascular, Inc. · PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE37 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.