Bard® Goodwin Sound 042830Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741047312), received between Jul 16, 2020 and Mar 2, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Corroded” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A PARTIAL ORDER OF QUITE A FEW GOODWIN SOUND REPLACEMENTS AS IT HAD CONSISTENTLY HAD ISSUES WITH RUST 042822 AND 042820 AND DISCOLORATION 042816 AND 042814 IN THE LUMEN. IT WAS ALSO STATED UPON RECEIVING THE NEW REPLACEMENTS, THEY WERE INSPECTED WITH A BORESCOPE AND DISCOLORATION WAS NOTED PRIOR TO ANY REPROCESSING. PER FOLLOW UP VIA EMAIL ON 16AUG2021, THE LOT NUMBERS OF THE AFFECTED SOUNDS WHICH ARE MIXED WITH NEW BOX AND NEVER PROCESSED. THE NEW BOX, WHICH WAS PROCESSED INITIALLY, NEVER USED ON PATIENT. THIS WAS THE ONGOING ISSUE FOR THE CUSTOMER AND CONSISTENTLY REPLACING THESE. THE CUSTOMER CHECKED AND VERIFIED INTERNAL PROCESS AND FOLLOW THE IFU VERBATIM, FLUSHING WITH STERILE WATER AT POINT OF USE. THE BOX AND PACKAGING THAT CUSTOMER RECEIVED WAS FOR 11 SOUNDS. THEY HAVE TOTAL OF 24 SOUNDS 042824 AND 042826.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13652550 ↗
• MalfunctionAug 9, 2021Corroded; Corroded

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A PARTIAL ORDER OF 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12293564 ↗
• MalfunctionJul 16, 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, 042822, 042830, 042828, 042820, 042826 AND 042824.

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

  MAUDE report 10284894 ↗