NA R10439072Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888551044363), received between Nov 29, 2023 and Nov 29, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K110076); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionNov 29, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION WITH A REPROCESSED IMAGING CATHETER AND WHEN THE PACKAGE WAS OPENED, THERE WAS A SUBSTANCE THAT LOOKED LIKE BLOOD ON THE HANDLE. THE HOSPITAL STAFF WIPED OFF THE HANDLE WITH THE GAUZE AND SET ASIDE THE CATHETER. THERE WAS NO REPORTED PATIENT CONSEQUENCE. 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 18234721 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110076. One submission often covers many models, so check the product and lot details in each record.

• Z-0059-2015 · Sep 24, 2014 · Terminated
  Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.