Cantata G54535Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002545356), received between Sep 6, 2018 and Sep 6, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Melted” (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.

• MalfunctionSep 6, 2018Melted; Melted

  IT WAS REPORTED A CANTATA 2.8 SUPERSELECTIVE MICROCATHETER WAS USED FOR CHEMO EMBOLIZATION TARGETING A HEPATIC TUMOR. THE CANTATA CATHETER WAS IN PLACE FOR A TOTAL TIME OF AROUND 1 HOUR. THE CANTATA WAS INITIALLY FLUSHED WITH HEPARINIZED SOLUTION BEFORE THE CHEMO MIX WAS DELIVERED. THE CHEMO MIX CONSISTED OF 20MG MITOMYCIN, 30MG OF DOXORUBICIN, IOTHALAMATE MEGLUMINE, 10ML OF LIPIODOL, AND 60% 10ML CONTRAST (EITHER 320 OR 350 MG/ML VISIPAQUE). IN GIVING THE CHEMO AGENT, THE PHYSICIAN ALTERNATED 1CC LIDOCAINE AND 3CC OF CHEMO MIX. FOUR CHEMO EMBOLIZATION DOSES WERE ABLE TO BE DELIVERED THROUGH THE CATHETER. AFTER THE FIRST FOUR DOSES WERE DELIVERED THE SYRINGE WAS UNABLE TO BE REMOVED FROM THE CATHETER DUE TO THE CATHETER HUB "MELTING" TO THE SYRINGE. HE ALSO CONFIRMED THAT HE DID NOT USE A STOPCOCK DURING THE CASE AND DID USE A CARBON FIBER SYRINGE. PICTURES OF THE DEVICE WERE REQUESTED BUT ARE NOT AVAILABLE. THE REPORTER STATED THE CATHETER AND SYRINGE WERE NOT SAVED SINCE THEY CONTAINED THE CHEMO EMBOLIZATION AGENT. THE CATHETER WAS CUT AND A BOSTON SCIENTIFIC DIREXION CATHETER WAS PLACED USING A 300CM EXCHANGE WIRE. THIS MICROCATHETER ADMINISTERED THE THREE REMAINING DOSES. THE T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7853083 ↗