CORODYN 601278-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046955651634), received between Sep 30, 2022 and Sep 30, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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.

• MalfunctionSep 30, 2022Obstruction of Flow; Difficult to Advance; Obstruction of Flow; Difficult to Advance

  AS REPORTED BY THE USER FACILITY: EVENT 2 EVENT DESCRIPTION:COULD NOT GET AN 025 WIRE (AND THEY MENTIONED 018" AS WELL) THROUGH THE ENDHOLE OF THE CATHETERS ON SEVERAL DIFFERENT OCCASIONS. ALSO, THE DOCTOR SAID HE TRIED USING AN .025" TIP DELECTING WIRE AND IT WOULDN'T GO TO THE ENDHOLE EVEN. HE SAID IT STOPPED A GOOD AMOUNT BEFORE THE ENDHOLE (1CM?) AND DEFINITELY WOULDN'T GO THROUGH SO HE WASN'T ABLE TO DEFLECT THE TIP OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15519693 ↗
• MalfunctionSep 30, 2022Obstruction of Flow; Difficult to Advance; Obstruction of Flow; Difficult to Advance

  AS REPORTED BY THE USER FACILITY: EVENT 1 EVENT DESCRIPTION:COULD NOT GET AN 025 WIRE (AND THEY MENTIONED 018" AS WELL) THROUGH THE ENDHOLE OF THE CATHETERS ON SEVERAL DIFFERENT OCCASIONS. ALSO, THE DOCTOR SAID HE TRIED USING AN .025" TIP DELECTING WIRE AND IT WOULDN'T GO TO THE ENDHOLE EVEN. HE SAID IT STOPPED A GOOD AMOUNT BEFORE THE ENDHOLE (1CM?) AND DEFINITELY WOULDN'T GO THROUGH SO HE WASN'T ABLE TO DEFLECT THE TIP OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15519386 ↗
• MalfunctionSep 30, 2022Obstruction of Flow; Difficult to Advance; Obstruction of Flow; Difficult to Advance

  AS REPORTED BY THE USER FACILITY: EVENT 3: EVENT DESCRIPTION:COULD NOT GET AN 025 WIRE (AND THEY MENTIONED 018" AS WELL) THROUGH THE ENDHOLE OF THE CATHETERS ON SEVERAL DIFFERENT OCCASIONS. ALSO, THE DOCTOR SAID HE TRIED USING AN .025" TIP DELECTING WIRE AND IT WOULDN'T GO TO THE ENDHOLE EVEN. HE SAID IT STOPPED A GOOD AMOUNT BEFORE THE ENDHOLE (1CM?) AND DEFINITELY WOULDN'T GO THROUGH SO HE WASN'T ABLE TO DEFLECT THE TIP OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15519385 ↗