Bard® Goodwin Sound 042828Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741047305), received between Jul 17, 2020 and Mar 1, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Corroded” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A PARTIAL ORDER OF QUITE A FEW GOODWIN SOUND REPLACEMENTS AS IT CONSISTENTLY HAD ISSUES WITH RUST AND DISCOLORATION IN THE LUMEN. ALSO STATED THAT UPON RECEIVING THE NEW REPLACEMENTS, THEY WERE INSPECTED WITH A BORESCOPE AND DISCOLORATION WAS NOTED PRIOR TO ANY REPROCESSING. PER NOTIFICATION FROM INVESTIGATOR ON (B)(6) 2022 BASED ON SAMPLE RETURNED, IT WAS REPORTED THAT THE DILATION CATHETERS WERE CORRODED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13636011 ↗
• MalfunctionJul 17, 2020Corroded

  IT WAS REPORTED THAT THE GOODWIN SOUND DILATORS HAD DETERMINED TO BE RUSTING INSIDE THE LUMEN OF THE SOUND. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 24JUN2020, THE COMPLAINANT PROVIDED 6 PRODUCT CATALOG NUMBER WITH THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 10288458 ↗