Cantata G54530Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002545301), received between Mar 31, 2017 and Sep 17, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 17, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT A CANTATA 2.5 SUPERSELECTIVE MICROCATHETER WAS TO BE USED DURING AN UNKNOWN PROCEDURE. THE DEVICE WAS FLUSHED DURING PRE-OPERATIONAL PREPARATION AND IT WAS NOTED THAT THE HUB HAD SEPARATED FROM THE CATHETER PRIOR TO USE. A LIKE DEVICE WAS OPENED AND USED SUCCESSFULLY TO COMPLETE THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 7882858 ↗
• MalfunctionMar 31, 2017Leak/Splash; Leak/Splash

  INTERNATIONAL CUSTOMER REPORTED THAT THE CANTATA SUPERSELECTIVE MICROCATHETER WAS INTENDED FOR USE IN AN UNSPECIFIED INDICATION. CUSTOMER REPORTED THAT NORMAL SALINE DRIPPED OUT FROM THE HUB WHILE THE PHYSICIANS WAS FLUSHING THE DEVICE. NO FURTHER EVENT OR PATIENT RELATED INFORMATION WAS PROVIDED. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCES. IT IS OPINED THAT THE PHYSICIAN OBTAINED AN UNSPECIFIED REPLACEMENT DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6450185 ↗