AcuNav 8F Ultrasound Catheter 10135936Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04056869001029), received between Sep 22, 2017 and Aug 26, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K042593, K071234, K170263); 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50462194 ↗
• MalfunctionAug 26, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50461994 ↗
• MalfunctionAug 26, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50461945 ↗
• MalfunctionFeb 18, 2026Appropriate Device Problem Term/Code Not Available

  THE PHYSICIAN HAS STATED TODAY THAT DURING A PROCEDURE THAT REQUIRED TRANSEPTAL PUNCTURE THEY TRIED TO USE 2 ECO CATHETERS BUT NON-OF THEM WORKED AND THEY FINALLY PROCEEDED THE TX PUNCTURE ONLY WITH FLUOROSCOPY. NO PATIENT CONSEQUENCES WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES, IF YES, NUMBER OF MINUTES: 12, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE

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

  MAUDE report 24376641 ↗
• MalfunctionFeb 18, 2026Appropriate Device Problem Term/Code Not Available

  1. SITUATION ACUNAV CATHETER WAS USED WHEN USING ANOTHER COMPANY'S SYSTEM. 1) LOT QE427994: THE CONNECTION WITH THE SWIFT LINK PART DID NOT FIT PROPERLY. REPLACED THE CATHETER, LOT QE428136. 2) LOT QE428136: ALTHOUGH THE CONNECTION WAS MADE WITHOUT ANY PROBLEMS, THE IMAGE SUDDENLY DISAPPEARED DURING ECHO IMAGING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY SWITCHING TO ANOTHER COMPANY'S ULTRASOUND MACHINE. 2. TIMING DURING CABLE CONNECTION AFTER OPENING THE STERILIZATION PACKAGE. 3. HOW TO COMPLETE THE PROCEDURE CONTENTS OF THE ABOVE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. THE COMPLAINT PRODUCT(S) WILL NOT BE RETURNED FOR ANALYSIS. WHEN THE EVENT OCCURRED ACUNAV CATHETER (LOT# QE427994) --- PRE-OP ACUNAV CATHETER (LOT# QE428136) --- INTRA-OP.

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

  MAUDE report 24376633 ↗
• MalfunctionFeb 18, 2026Appropriate Device Problem Term/Code Not Available

  1. SITUATION ACUNAV CATHETER WAS USED WHEN USING ANOTHER COMPANY'S SYSTEM. 1) LOT QE427994:THE CONNECTION WITH THE SWIFT LINK PART DID NOT FIT PROPERLY. REPLACED THE CATHETER, LOT QE428136. 2)LOT QE428136: ALTHOUGH THE CONNECTION WAS MADE WITHOUT ANY PROBLEMS, THE IMAGE SUDDENLY DISAPPEARED DURING ECHO IMAGING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY SWITCHING TO ANOTHER COMPANY'S ULTRASOUND MACHINE. 2. TIMING DURING CABLE CONNECTION AFTER OPENING THE STERILIZATION PACKAGE. 3. HOW TO COMPLETE THE PROCEDURE CONTENTS OF THE ABOVE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. THE COMPLAINT PRODUCT(S) WILL NOT BE RETURNED FOR ANALYSIS. WHEN THE EVENT OCCURRED ACUNAV CATHETER (LOT# QE427994) --- PRE-OP ACUNAV CATHETER (LOT# QE428136) --- INTRA-OP.

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

  MAUDE report 24376631 ↗
• MalfunctionFeb 18, 2026Appropriate Device Problem Term/Code Not Available

  THE ARRHYTHMIA SPECIALIST INFORMED IN THAT IN A CRYOBALLOON ABLATION THE DAY PRIOR, THE ACUNAV CATHETER WAS OPENED. IT WAS CONNECTED TO THE SIEMENS P500 ULTRASOUND MACHINE IN THE NORMAL FASHION. WHEN TRYING TO SELECT THE CATHETER AS A TRANSDUCER, THE OPTION WAS NOT AVAILABLE. THE CATHETER CONNECTION SEQUENCE WAS REDONE; HOWEVER, THE ULTRASOUND SYSTEM WAS STILL NOT RECOGNIZING THE CATHETER. THE ULTRASOUND SYSTEM WAS RESTARTED AND THE CATHETER WAS CONNECTED TO THE SWIFTLINK. THE CATHETER WAS STILL NOT BEING RECOGNIZED BY THE ULTRASOUND SYSTEM. AN ABBOTT VIEWFLEX WAS OPENED INSTEAD USING THE VIEWMATE ULTRASOUND MACHINE. THE CASE CONTINUED WITHOUT FURTHER ISSUES. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES, IF YES, NUMBER OF MINUTES: 15, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES , WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I

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

  MAUDE report 24376627 ↗
• MalfunctionJan 16, 2026Loss of Data

  WHEN ATTEMPTING TO SAVE AN IMAGE, THE SAVE FAILED. THE ISSUE WAS NOT RESOLVED, BUT THE PROCEDURE WAS COMPLETED WITHOUT PROBLEMS. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24100638 ↗
• MalfunctionJul 26, 2024

  UNABLE TO DETECT ICE CATHETER ON MONITOR/NO IMAGE. AFTER TROUBLESHOOTING MACHINE, EXISTING ICE CATHETER REMOVED FROM THE BODY, AND NEW CATHETER PLACED WITH NO ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19837646 ↗
• MalfunctionSep 26, 2017No Display/Image; No Display/Image

  IT WAS REPORTED THAT PRIOR TO A VENTRICULAR TACHYCARDIA (VT) PROCEDURE, THE CATHETER WAS CONNECTED TO THE ULTRASOUND SYSTEM AND INSERTED INTO THE PATIENT'S ANATOMY. IN THE MIDDLE OF THE PROCEDURE, IT WAS OBSERVED THAT THERE WAS NO IMAGE BEING DISPLAYED ON THE ULTRASOUND SYSTEM. THE CATHETER WAS REMOVED AND A REPLACEMENT CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 6894524 ↗
• InjurySep 22, 2017Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT A PATIENT WAS PUT UNDER ANESTHESIA AND UNDERWENT AN ATRIAL FIBRILLATION (AFIB) CRYOBALLOON ABLATION PROCEDURE. THE CATHETER WAS INSERTED INTO THE PATIENT AND WHILE THE DOCTOR WAS EVALUATING THE HEART WITH AN INTRACARDIAC CATHETER (ICE), A POOR ACOUSTIC IMAGING WAS GENERATED BY THE CATHETER. THE DOCTOR REMOVED THE CATHETER AND REINSERTED A NEW CATHETER TO COMPLETE THE PROCEDURE USING THE SAME ULTRASOUND SYSTEM. THE PROCEDURE WAS DELAYED BY FIVE MINUTES WHILE A REPLACEMENT CATHETER WAS PREPARED. LATER IN THE PROCEDURE, AFTER THE TRANSEPTAL PUNCTURE, THE PATIENT DEVELOPED PERICARDIAL EFFUSION. IN ORDER TO IMMEDIATELY STABILIZE THE PATIENT, THE DOCTOR PERFORMED PERICARDIOCENTESIS AND ASPIRATED 300CCS OF FLUID. IT IS UNKNOWN WHETHER THIS WAS A RESULT OF THE REPORTED EVENT; HOWEVER, THE INITIAL REPORT STATED THAT THE PERICARDIAL EFFUSION WAS UNRELATED TO THE CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pericardial Effusion

  MAUDE report 6888402 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042593, K071234, K170263. 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.