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Cantata G34582Recalls & reported problems

Cook Incorporated · Cantata, 2.9 Microcatheter · Class 2

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002345826), received between Sep 14, 2017 and Nov 1, 2017 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 reports).

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

Device problems

  • Leak/Splash3
  • Device Contamination with Chemical or Other Material1
  • Material Separation1

Patient problems

  • No Information2
  • No Patient Involvement2
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 1, 2017Leak/Splash

    THE USER NOTED THAT THE DEVICE WAS LEAKING FROM THE HUB PRIOR TO THE PROCEDURE.

    Patient problems: No Information

    MAUDE report 6993421 ↗
  • MalfunctionNov 1, 2017Leak/Splash

    THE FOLLOWING INFORMATION WAS REPORTED: THEY WERE DOING ONE LAST CONTRAST RUN BEFORE TREATING WITH Y90. AS THEY WERE HAND-INJECTING, THEY NOTICED LEAKING AROUND HUB. THE POTENTIAL PROBLEM IS THAT Y90 (YTTRIUM) IS RADIOACTIVE AND IF THE CANTATA HAD LEAKED WITH THE Y90 INSTEAD OF CONTRAST, THE ENTIRE CONTENTS OF THE ROOM COULD HAVE BECOME CONTAMINATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER CANTATA AND THERE WERE NO REPORTED ADVERSE EFFECTS AS A RESULT OF THIS PRODUCT PROBLEM.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6993376 ↗
  • MalfunctionOct 31, 2017Material Separation

    PRIOR TO THE PROCEDURE IN PREPARING THE CANTATA 2.9 SUPERSELECTIVE MICROCATHETER, THE CATHETER WAS FLUSHED, THE SYRINGE WAS CONNECTED TO THE HUB AND WHEN THEY ATTEMPTED TO PUSH THE SALINE THROUGH THE HUB SEPARATED FROM THE CATHETER. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THIS DEVICE DID NOT MAKE CONTACT WITH THE PATIENT.

    Patient problems: No Patient Involvement

    MAUDE report 6991092 ↗
  • MalfunctionOct 31, 2017Leak/Splash

    PRIOR TO PATIENT CONTACT, THE TECH FLUSHED THE MICROCATHETER AND NOTICED THAT IT WAS LEAKING WHERE IT CONNECTED TO THE HUB.

    Patient problems: No Information

    MAUDE report 6990442 ↗
  • MalfunctionSep 14, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    FOUND HAIR IN UNOPENED CANTATA PACKAGING. THE CUSTOMER REPORTED THAT, UPON INSPECTION OF THE CANTATA 2.9 SUPERSELECTIVE MICROCATHETER, A HAIR WAS DISCOVERED IN THE PACKAGING. THE DEVICE WAS NOT OPENED; ACCORDINGLY, NO PATIENT CONTACT WAS MADE, AND NO ADVERSE EVENTS OCCURRED. THE CUSTOMER DECLINED TO PROVIDE ADDITIONAL INFORMATION REGARDING THE INCIDENT. THE PRODUCT WAS RETURNED FOR EVALUATION, AND THE INVESTIGATION IS CURRENTLY PENDING.

    Patient problems: No Patient Involvement

    MAUDE report 6865503 ↗

Other Catheter, continuous flush devices

All Catheter, continuous flush devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.