AcuNav G 8F Ultrasound Catheter 10135910Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04056869001043), received between Feb 4, 2025 and Sep 29, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K071234); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Poor Quality Image

  Patient problems: Insufficient Information

  MAUDE report 50936330 ↗
• MalfunctionAug 26, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50461881 ↗
• MalfunctionAug 26, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50461760 ↗
• MalfunctionFeb 18, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE CALLER, CLINICAL ACCOUNT SPECIALIST THAT THE ACUSON ACUNAV¿ ULTRASOUND CATHETER WAS CONNECTED AND THE IMAGE DID NOT DISPLAY ON THE ULTRASOUND SYSTEM. THE CALLER NOTED THAT THE SWIFTLINK WAS NOT RECOGNIZED BY THE ULTRASOUND SYSTEM WHEN IT WAS CONNECTED TO THE CATHETER. THE CATHETER WAS RESEATED WITHOUT RESOLUTION. THE CATHETER WAS REPLACED WITHOUT RESOLUTION. THE ULTRASOUND SYSTEM AND CATHETER WERE BOTH REPLACED WITH A "ST JUDE'S," AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. THE CALLER REQUESTED TWO REPLACEMENT CATHETERS. THE CALLER STATED THAT BOTH CATHETERS ARE NOT AVAILABLE FOR RETURN. PROCEDURE: TIPS THE CALLER NOTED THAT THE CARTO¿ 3 SYSTEM WAS NOT USED THE CALLER NOTED THAT NO ABLATION GENERATOR WAS USED. THE CALLER WAS ADVISED TO CONTACT GE CUSTOMER SERVICE REGARDING THE ULTRASOUND SYSTEM. DOCUMENTATION APPROVED BY CSS (B)(6).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24376622 ↗
• MalfunctionFeb 4, 2025

  ICE (INTRACARDIAC ECHOCARDIOGRAPHY) CATHETER INSERTED INTO BODY AND IMAGE BLURRY, ZERO VISUALIZATION. DIFFERENT ICE CATHETER OPENED, PROBLEM RESOLVED.

  Patient problems: Insufficient Information

  MAUDE report 21303498 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071234. One submission often covers many models, so check the product and lot details in each record.

• Z-1745-2011 · Mar 20, 2009 · Terminated
  Siemens Medical Solutions USA, Inc., ACUSON AcuNav ultrasound catheters when using SwiftLink catheter connectors; Model Number: 10348560.