Bard® PTFE Felt 007837Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741000195), received between Jan 19, 2018 and Jan 24, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2023Contamination; Device Handling Problem; Contamination; Device Handling Problem

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE PTFE FELT ALLEGEDLY FELL TO THE FLOOR. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16231840 ↗
• MalfunctionJul 11, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 7837 PTFE FELT ALLEGEDLY EXPERIENCED FOREIGN MATERIAL PRESENT IN DEVICE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION REPORTED NO PATIENT INVOLVEMENT. THE PATIENT¿S AGE, WEIGHT, AND SEX WAS NOT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8782945 ↗
• MalfunctionNov 16, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT UPON OPENING THE DEVICE PACKAGE, A FOREIGN MATERIAL WAS ALLEGEDLY IDENTIFIED ON THE SURFACE OF THE DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8081959 ↗
• MalfunctionJun 26, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING PREPARATION FOR THE PROCEDURE, THERE WAS ALLEGEDLY FOREIGN MATERIAL FOUND ON THE PACKAGING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7638708 ↗
• InjuryJan 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST PTFE FELT IMPLANT, THE PATIENT ALLEGEDLY EXPERIENCED REPEATED PAIN AND INFECTION AND WAS HOSPITALIZED MULTIPLE TIMES. IT WAS FURTHER REPORTED THAT TWO AND A HALF YEARS POST IMPLANT, THE PTFE FELT WAS REMOVED FROM THE PATIENT. REPORTEDLY, THE PATIENT IS ASYMPTOTIC POST THE REMOVAL.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7205633 ↗