Ultra ICE Plus M00499100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729904373), received between Mar 15, 2018 and Mar 15, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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. 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.

• MalfunctionMar 15, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CATHETER BREAK / DETACHMENT OCCURRED. AN ULTRA ICE PLUS ULTRASOUND IMAGING CATHETER AND ANOTHER MANUFACTURER¿S SNARE WERE SELECTED FOR USE DURING AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEAD EXTRACTION PROCEDURE IN THE RIGHT ATRIUM. DURING A TWISTING MANEUVER WITH THE SNARE RETRIEVAL DEVICE, THE CATHETER WAS ENTRAPPED WHILE IT WAS ROTATING AND THEREFORE BECAME DAMAGED. DURING RETRIEVAL OF THE DEVICES, THE PIEZOELECTRIC CRYSTAL BROKE AND DETACHED FROM THE CATHETER BODY. IT WAS NOTED THE DETACHMENT ¿PROBABLY¿ OCCURRED INSIDE THE SHEATH. ALL COMPONENTS WERE REMOVED FROM THE PATIENT WITHOUT PROBLEMS AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7341241 ↗