Cantata G54531Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002545318), received between Jul 28, 2017 and Aug 8, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2019Material Separation; Material Separation

  NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 29AUG2019.

  Patient problems: No Code Available

  MAUDE report 8873352 ↗
• InjuryJul 28, 2017Break; Break

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS DIAGNOSED BY CT ( COMPUTED TOMOGRAPHY) SCAN WITH AN ABDOMINAL BLEED. THE ETIOLOGY OF THE BLEED WAS NOT IDENTIFIED. THE PATIENT WAS UNDERGOING A PROCEDURE TO LOCATE AND EMBOLIZE THE SOURCE OF THE BLEED. THE PHYSICIAN ATTEMPTED TO LOCATE THE SOURCE OF THE BLEED BY PROBING THE TRUNCUS WITH A COMPETITOR PRODUCT AND PROBING THE LEFT GASTRIC ARTERY WITH A CANTATA DUO 2.5 SUPERSELECTIVE MICROCATHETER. THE PHYSICIAN PULLED THE CANTATA DUO 2.5 SUPERSELECTIVE MICROCATHETER IN ORDER TO PROBE THE AMS WITH THE COMPETITOR PRODUCT. A PORTION OF THE MICROCATHETER REMAINED WITHIN THE AORTA AT THE TIP OF THE COMPETITOR PRODUCT WHILE ATTEMPTING TO REMOVE THE DEVICE. THE BROKEN PORTION WAS RETRIEVED USING A SLING DEVICE AND REMOVED THROUGH A SECOND 4 FR CATHETER. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 6751014 ↗