Bard® Goodwin Sound 042812Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741047220), received between Aug 8, 2021 and Feb 28, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Corroded” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 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 042816AND 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 16AUG21, 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 13625907 ↗
• MalfunctionFeb 28, 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 13625905 ↗
• MalfunctionSep 10, 2021Corroded; Corroded

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A PARTIAL ORDER OF A QUITE FEW GOODWIN SOUND REPLACEMENTS AS IT HAD CONSISTENTLY ISSUES WITH RUST AND DISCOLORATION IN THE LUMEN. 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 16AUG21, 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 THE POINT OF USE. THE BOX AND PACKAGING THAT CUSTOMER RECEIVED WAS FOR 11 SOUNDS. THEY HAVE TOTAL OF 24 SOUNDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12452460 ↗
• MalfunctionAug 8, 2021Corroded; Corroded

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A PARTIAL ORDER OF QUITE A FEW GOODWIN SOUNDED REPLACEMENTS AS IT HAD CONSISTENTLY ISSUES WITH RUST AND DISCOLORATION IN THE LUMEN. IT WAS ALSO STATED UPON RECEIVING THE NEW REPLACEMENTS, THEY ARE INSPECTED WITH A BORESCOPE AND DISCOLORATION WAS NOTED PRIOR TO ANY REPROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12292203 ↗