Cantata G34583Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002345833), received between Mar 10, 2017 and Aug 22, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2023Material Separation; Device-Device Incompatibility; Difficult to Advance; Material Separation; Device-Device Incompatibility; Difficult to Advance

  ADDITIONAL INFORMATION WAS PROVIDED. AS REPORTED, THE PROCEDURE WAS TO TREAT A RLL (RIGHT LOWER LOBE) PAVM (PULMONARY ARTERIOVENOUS MALFORMATION). THE FEEDING PULMONARY ARTERY WAS SOMEWHAT TORTUOUS BUT NOT CALCIFIED; HOWEVER, THE TORTUOSITY WAS NOT OUT OF THE ORDINARY FOR A PAVM. THE PHYSICIAN ROUTINELY USES THE CANTATA IN THIS AREA. IN THIS EVENT, A 0.035 WIRE GUIDE AND A 0.014 WIRE GUIDE ADVANCED TO THE DISTAL FEEDING PULMONARY ARTERY WITHOUT DIFFICULTY. HOWEVER, THE CANTATA CATHETER WOULD NOT ADVANCE WELL OVER THE WIRE. DURING ATTEMPTED ADVANCEMENT OF A VASCULAR PLUG THROUGH THE CANTATA, THE PLUG BECAME STUCK AND WOULD NOT ADVANCE. AFTER THE PLUG WAS REMOVED, SMALL PARTICLES IN THE BLOOD WERE NOTED DURING ASPIRATION. THE CANTATA WAS SUBSEQUENTLY REMOVED AND EXAMINED; IT WAS DISCOVERED THAT THE COATING SEEMED TO BE MISSING. ADDITIONAL BLOOD WAS RAPIDLY ASPIRATED FROM THE FEEDING PULMONARY ARTERY. THERE WAS A HIGH RISK FOR PARADOXICAL EMBOLIZATION AND COMPLICATION AS THIS OCCURRED AT THE LOCATION OF THE AVM. THEN AN ADDITIONAL 2.9 FRENCH CANTATA WAS OBTAINED AND WAS EASILY ADVANCED TO THE AVM SITE FOR SUCCESSFUL EMBOLIZATION WITH THE VASCULAR PLUG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596809 ↗
• MalfunctionMar 10, 2017Material Separation; Material Separation

  INTERNATIONAL DISTRIBUTOR REPORTED THAT THE WHITE HUB OF THE CANTATA DETACHED WHILE ATTEMPTING TO INSERT THE DEVICE FOR A UTERINE FIBROID EMBOLIZATION PROCEDURE. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES ASSOCIATED WITH THIS EVENT. NO LEAKS OR OTHER SEPARATIONS WERE NOTED. THE DEVICE WAS DISPOSED AT THE USER FACILITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6395139 ↗