N/A (REF 10135936)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00885825011376), received between Feb 6, 2020 and Jul 21, 2021 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (14 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THE ACUNAV WAS DEFECTIVE. THE ACUNAV DIDN'T WORK AND FAILED TO CONNECT. THE ORIGINAL PLANNED PROCEDURE WAS INTRA-ATRIAL SHUNT PLACEMENT, USING THE DEVICE TO ASSIST WITH TRANS-SEPTAL PROCEDURE. DUE TO THE ACCUNAV CATHETER BEING DEFECTIVE, AN HOUR WAS SPENT TRYING TO TROUBLE SHOOT THE MACHINES AND RESULTED IN A CONVERSION TO TEE ( TRANS ESOPHAGEAL ECHO).  THE TEE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12207378 ↗
• InjuryJul 21, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THE ACUNAV WAS DEFECTIVE. THE ACUNAV DIDN'T WORK AND FAILED TO CONNECT. THE ORIGINAL PLANNED PROCEDURE WAS INTRA-ATRIAL SHUNT PLACEMENT, USING THE DEVICE TO ASSIST WITH TRANS-SEPTAL PROCEDURE. DUE TO THE ACUNAV CATHETER BEING DEFECTIVE, AN HOUR WAS SPENT TRYING TO TROUBLE SHOOT THE MACHINES AND RESULTED IN A CONVERSION TO TRANS ESOPHAGEAL ECHO (TEE).  THE TEE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12207167 ↗
• MalfunctionJun 11, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THE ULTRASOUND IMAGE FROM THE DIAGNOSTIC ULTRASOUND CATHETER HAD AN ARTIFACT AND WAS VERY GRAINY. THE IMAGE WAS TOO BRIGHT AND THERE WERE GRAY STREAKS. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10144043 ↗
• MalfunctionApr 30, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THE DIAGNOSTIC ULTRASOUND CATHETER (DUC) HAD VERY POOR IMAGE DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10014146 ↗
• MalfunctionApr 30, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THE DIAGNOSTIC ULTRASOUND CATHETER (DUC) HAD VERY POOR IMAGE DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10014138 ↗
• MalfunctionApr 27, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THERE WAS POOR IMAGE QUALITY. IMAGE WAS TOO DARK FROM THE BEGINNING OF THE CASE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 3 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10003379 ↗
• MalfunctionApr 22, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THERE WAS POOR IMAGE QUALITY. IMAGE WAS TOO DARK FROM THE BEGINNING OF THE CASE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 3 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9986815 ↗
• MalfunctionApr 13, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THERE WAS POOR CONTRAST. IMAGE WAS TOO DARK AND TOO FUZZY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 5 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9955600 ↗
• MalfunctionApr 13, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THE CATHETER HAD POOR IMAGE QUALITY AT THE BEGINNING OF THE CASE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 5 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9954590 ↗
• MalfunctionApr 1, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THE CATHETER HAD A POOR IMAGE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9914474 ↗
• MalfunctionApr 1, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED NO IMAGE AVAILABLE FOR TRANS-SEPTAL DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9914473 ↗
• MalfunctionMar 23, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THE CATHETER HAD POOR QUALITY IMAGE. IMAGE WAS TOO DARK AND NO ARTIFACTS WERE IDENTIFIED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME WAS REPORTED TO BE A 5 TO 10 MINUTE DELAY. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9869399 ↗
• MalfunctionMar 9, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THERE WAS BAD IMAGE QUALITY ON THE ULTRASOUND MACHINE. THERE WAS NO PATIENT INJURY REPORTED AND THE COMPLAINANT WAS UNAWARE OF ANY MEDICAL INTERVENTION OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9808882 ↗
• MalfunctionMar 6, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THE DIAGNOSTIC ULTRASOUND CATHETER HAD POOR IMAGE QUALITY. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9803186 ↗
• MalfunctionMar 6, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THE DIAGNOSTIC ULTRASOUND CATHETER WAS DEFECTIVE; IT HAD VERY POOR IMAGE QUALITY. THE COMPLAINANT IS NOT AWARE OF ANY PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9803185 ↗
• MalfunctionFeb 6, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THE DIAGNOSTIC ULTRASOUND CATHETER WAS PLUGGED IN AND EVERYTHING WAS FINE BUT THE IMAGE QUALITY WAS DARK. THE PHYSICIAN COULD NOT PERFORM THE CASE THE WAY HE WANTED TO. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS APPROXIMATELY 20 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9677663 ↗