Bard PTFE Felt PledgetsRecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 71
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 3 models of Bard PTFE Felt Pledgets by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 71 adverse event reports in the FDA's MAUDE database, received between May 5, 2021 and Mar 11, 2026 — classified as 71 malfunctions.
The most frequently reported specific device problem is “Incomplete or Missing Packaging” (37 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Bard PTFE Felt Pledgets problems
Device problems
- Incomplete or Missing Packaging37
- Device Contamination with Chemical or Other Material33
- Missing Information4
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions71
Bard PTFE Felt Pledgets models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bard® PTFE Felt Pledgets 007963PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE37 reports
- Bard® PTFE Felt Pledgets 007970PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE33 reports
- Bard® PTFE Felt Pledgets 007965PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE1 report
Recent Bard PTFE Felt Pledgets adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2026Tear, Rip or Hole in Device Packaging
A PATIENT UNDERWENT A SURGICAL GRAFT IMPLANTATION PROCEDURE. PRIOR TO THE PROCEDURE, THE INNER SLEEVE PACKAGE IS IN OPENED STATE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24567060 ↗MalfunctionNov 28, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669435 ↗MalfunctionNov 28, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669434 ↗MalfunctionNov 28, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669433 ↗MalfunctionNov 28, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669432 ↗MalfunctionNov 28, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669380 ↗MalfunctionNov 28, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669378 ↗MalfunctionNov 28, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669377 ↗MalfunctionNov 28, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669375 ↗MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654211 ↗MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654206 ↗MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654149 ↗MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654087 ↗MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654047 ↗MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654046 ↗
Other Bard Peripheral Vascular, Inc. products
- MAX-CORE11 models · 8,845 reports · 1 recall
- DENALI Vena Cava Filter2 models · 1,021 reports
- MAGNUM19 models · 571 reports · 1 recall
- Conquest32 models · 560 reports
- Ultraverse RX56 models · 536 reports
- Fluency Endovascular Stent Graft51 models · 532 reports
- Atlas Gold33 models · 427 reports
- Ultraverse 035 PTA Dilatation Catheter92 models · 393 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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