Cantata G54536Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002545363), received between May 5, 2017 and May 5, 2017 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2017Leak/Splash; Leak/Splash

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING PLACEMENT OF A CANTATA 2.8 SUPERSELECTIVE MICROCATHETER FOR AN UNSPECIFIED INDICATION. THE PHYSICIAN WAS USING A COMPETITORS' GUIDE WIRE WITHIN THE CATHETER DURING PLACEMENT. THE PHYSICIAN ATTEMPTED TO FLUSH THE CATHETER WITH THE GUIDE WIRE IN PLACE TO VERIFY PROPER CATHETER TIP PLACEMENT; NO FLUID CAME OUT OF THE TIP. THE PHYSICIAN THEN REMOVED THE CATHETER AND ATTEMPTED TO FLUSH THE DEVICE. IT WAS REPORTED THAT FLUID WENT OUT OF A HOLE ON THE SIDE OF THE CATHETER. THE CUSTOMER OPINES THAT THE "CATHETER HAS BEEN HOLED BY THE GUIDE WIRE." THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES RELATED TO THIS EVENT. THE DEVICE IS AVAILABLE FOR EVALUATION, HOWEVER IT HAS NOT BEEN RETURNED TO THE MANUFACTURER AS OF THE DATE OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6547003 ↗