Cantata G23805Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002238050), received between Jun 15, 2017 and Nov 11, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2020Material Separation; Material Separation

  IT WAS REPORTED A MALE PATIENT REQUIRED PLACEMENT OF A CANTATA DUO 2.8 SUPERSELECTIVE MICROCATHETER FOR A SPLENIC EMBOLIZATION PROCEDURE. AFTER THE COILS WERE PLACED, THE OPERATOR NOTED THAT THE CATHETER BROKE INSIDE OF THE PATIENT, ABOUT 10CM FROM THE DISTAL END. THE OPERATOR RETRIEVED THE SEPARATED PORTION WITH A SNARE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 10825513 ↗
• MalfunctionSep 11, 2018Material Perforation; Material Perforation

  IT WAS REPORTED A CANTATA DUO 2.8 SUPERSELECTIVE MICROCATHETER WAS PLACED FOR A UTERINE FIBROID EMBOLIZATION IN A PATIENT WITH A TORTUOUS ANATOMY. DURING THE PROCEDURE, THE PHYSICIAN REMOVED THE CATHETER FOR ASSESSMENT. WHILE FLUSHING WITH SALINE AND CONTRAST SOLUTION WITH A 1 ML SYRINGE, IT WAS OBSERVED THAT A HOLE HAD FORMED IN THE PROXIMAL THIRD OF THE CATHETER. THE PROCEDURE CONTINUED WITH ANOTHER LIKE CATHETER WHICH ADDED TO THE PROCEDURE TIME, BUT DID NOT RESULT IN ANY ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7865119 ↗
• MalfunctionAug 14, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  FOREIGN MATERIAL WAS OBSERVED FREE-FLOATING WITHIN THE DEVICE PACKAGE. THE FOREIGN MATTER WAS OBSERVED DURING AN EVALUATION OF UNUSED SAMPLES RETURNED FOR A SEPARATE COMPLAINT INVESTIGATION. THERE WAS NO PATIENT CONTACT, ACCORDINGLY, NO ADVERSE PATIENT CONSEQUENCE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

  Patient problems: No Patient Involvement

  MAUDE report 6792669 ↗
• MalfunctionJun 15, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTED THAT A PATIENT UNDERWENT SUCCESSFUL PLACEMENT OF A CANTATA DUO 2.8 SUPERSELECTIVE MICROCATHETER FOR AN UNSPECIFIED INDICATION. THE RUBBER PART OF THE CATHETER SEPARATED FROM THE HUB AT THE TIME OF MEDICINAL INJECTION. THE CIRCUMSTANCES AND HANDLING CONDITIONS AT THE TIME OF FLUID INJECTION ARE NOT KNOWN. THE PHYSICIAN RECONNECTED THE RUBBER PART TO THE HUB AND PROCEEDED WITH UNEVENTFUL FLUID INJECTION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6643273 ↗