AcuNav G 10F Ultrasound Catheter 10043342Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04056869001036), received between Feb 6, 2026 and Aug 14, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50261485 ↗
• MalfunctionFeb 18, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE CALLER, CLINICAL ACCOUNT SPECIALIST THAT AFTER THE ACUSON ACUNAV¿ ULTRASOUND CATHETER WAS CONNECTED TO THE "GE" ULTRASOUND SYSTEM, THE CATHETER WAS NOT RECOGNIZED BY THE SYSTEM. THE SWIFLINK CONNECTER WAS RESEATED WITHOUT RESOLUTION. THE ULTRASOUND SYSTEM WAS RESTARTED WITHOUT RESOLUTION. THE CATHETER WAS REPLACED WITHOUT RESOLUTION. THE SWIFTLINK CONNECTOR WAS REPLACED, AND THE ISSUE PERSISTED. THE CALLER STATED THAT THE ULTRASOUND SYSTEM AND CATHETER WERE BOTH REPLACED WITH ANOTHER (VUE FLEX CATHETER) AND THE ISSUE RESOLVED. THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. THE CALLER IS REQUESTING TWO REPLACEMENT CATHETERS. THE CALLER STATED THAT THE ACUSON ACUNAV¿ ULTRASOUND CATHETERS ARE AVAILABLE FOR RETURN. RETURN KIT REQUESTED. THE CALLER NOTED THAT THE CARTO¿ 3 SYSTEM WAS NOT USED. THE CALLER NOTED THAT THE MEDTRONIC AFFERA WAS USED. DOCUMENTATION APPROVED BY CSS WS.

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

  MAUDE report 24376638 ↗
• MalfunctionFeb 18, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE S70 ULTRASOUND SYSTEM DISPLAYED A MESSAGE "PROBE NOT SUPPORTED" WHEN THE CATHETER WAS PLUGGED INTO THE S70 ULTRASOUND SYSTEM. CALLER RESEATED THE TRANSDUCER WITHOUT RESOLUTION. CALLER REBOOTED S70 ULTRASOUND SYSTEM WITHOUT RESOLUTION. THE CATHETER WAS REPLACED, AND THE ISSUE WAS NOT RESOLVED. CALLER SWITCHED TO THE MEDTRONIC ULTRASOUND MACHINE AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS CONTINUED. 2 REPLACEMENT CATHETER REQUESTED. SOFTWARE VERSION 8.1.1.944 MEDTRONIC GENERATOR WAS IN USE.

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

  MAUDE report 24376624 ↗
• MalfunctionFeb 6, 2026No Display/Image

  DURING AN UNKNOWN PROCEDURE, NO IMAGE WAS DISPLAYED WHEN THE CATHETER WAS CONNECTED. SURGERY WAS DELAYED BY 10 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24284759 ↗

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.