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Cantata G54534Recalls & reported problems

Cook Incorporated · Cantata, 2.8 Microcatheter · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002545349), received between Apr 20, 2017 and Apr 20, 2017 — classified as 1 malfunction.

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

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionApr 20, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

    CUSTOMER REPORTED THAT A CANTATA 2.8 SUPERSELECTIVE MICROCATHETER WAS BEING USED FOR AN UNSPECIFIED PROCEDURE. THE CUSTOMER STATED THAT THE HUB OF THE DEVICE CAME APART. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THE ATTENDING RADIOLOGIST STATED "I DON'T THINK THIS WAS DEFECTIVE. I THINK IT WAS USER ERROR." NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION, HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS REPORT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6508364 ↗

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.