Bard® PTFE Thick Felt Pledgets 007971Recalls & reported problems
Bard Peripheral Vascular, Inc. · Bard® PTFE Thick Felt Pledgets, (Round), 6 mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00801741041358), received between Mar 4, 2024 and Mar 4, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Leak/Splash” (2 reports).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash2
- Migration2
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 4, 2024Leak/Splash; Migration; Leak/Splash; Migration
IT WAS REPORTED THAT DURING A SURGICAL GRAFT PLACEMENT PROCEDURE, DURING HAEMOSTASIS, AT THE SECOND CLAMPING, THE NEW AORTIC SUTURE WAS ALLEGEDLY LOOSENED WITH A MASSIVE LEAKAGE WHICH REQUIRED A THIRD ONE HUNDRED AND SEVENTY SIX MINUTE CLAMPING. IT WAS FURTHER REPORTED THAT THE TEFLON PATCH ALLEGEDLY WENT INTO THE PATIENT'S BLOODSTREAM. REPORTEDLY, THE PATIENT WAS NEEDED TO BE REOPENED AND WAS PLACED UNDER CARDIOVASCULAR EXAMINATION ALONG WITH RAPID RECOVERY AND CLOSE NEUROLOGICAL MONITORING WAS DONE DUE TO THE MISSING PIECE OF TEFLON. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18825283 ↗InjuryMar 4, 2024Leak/Splash; Migration; Leak/Splash; Migration
IT WAS REPORTED THAT DURING A SURGICAL GRAFT PLACEMENT PROCEDURE, DURING HAEMOSTASIS, AT THE SECOND CLAMPING, THE NEW AORTIC SUTURE WAS ALLEGEDLY LOOSENED WITH A MASSIVE LEAKAGE WHICH REQUIRED A THIRD ONE HUNDRED AND SEVENTY SIX MINUTE CLAMPING. IT WAS FURTHER REPORTED THAT THE TEFLON PATCH ALLEGEDLY WENT INTO THE PATIENT'S BLOODSTREAM. REPORTEDLY, THE PATIENT WAS NEEDED TO BE REOPENED AND WAS PLACED UNDER CARDIOVASCULAR EXAMINATIONA ALONG WITH RAPID RECOVERY AND CLOSE NEUROLOGICAL MONITORING WAS DONE DUE TO THE MISSING PIECE OF TEFLON. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18825092 ↗
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- Peri-Guard PC0404NSynovis Life Technologies, 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
- SJM™ C0914St. Jude Medical, Inc. · PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE1 recall0 reports
- SJM™ C0510St. Jude Medical, Inc. · PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE1 recall0 reports
- CryoPatch® SG Pulmonary Human Cardiac Hemi-Artery Patch SGPH00Artivion, 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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