AVAIL F6QRD010RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835000528), received between Mar 10, 2022 and Apr 12, 2024 — classified as 2 malfunctions.

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

• MalfunctionApr 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH AN AVAIL¿ ELECTROPHYSIOLOGY CATHETER AND THE SHAFT MATERIAL WAS BROKEN. IT WAS REPORTED THAT DURING THE OPERATION, THE APPEARANCE OF THE FIXED BEND IS DAMAGED. THE SECOND CATHETER WAS USED TO COMPLETE THE OPERATION. THE PHYSICIAN DIDN¿T USE IT IN PATIENT AND SWITCHED ANOTHER NEW ONE TO COMPLETE THE OPERATION. THERE WAS NO REPORT ON ADVERSE EVENT ON PATIENT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19096769 ↗
• MalfunctionMar 10, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR RE-ENTRY TACHYCARDIA (AVRT) AND A WOLFF-PARKINSON-WHITE (WPW) ABLATION PROCEDURE WITH AN AVAIL¿ ELECTROPHYSIOLOGY CATHETER WHEREIN STERILIZATION OF THE DEVICE WAS COMPROMISED. IT WAS REPORTED THAT A WORM WAS OBSERVED ON THE SEAL OF PRIMARY PACKAGE; THE POUCH WAS NOT OPENED. A SECOND CATHETER WAS USED TO COMPLETE THE OPERATION. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT WILL BE CONSERVATIVELY REPORTED AS EVEN THOUGH THE WORM IS ON THE OUTER SEAL WHICH DOES NOT COMPROMISE STERILITY, HOWEVER, IT WAS DETERMINED THAT ONCE THE PACKAGE WAS OPENED, THE WORM WOULD COMPROMISE STERILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13717838 ↗