NA ACU10135936Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10888551004732), received between Dec 21, 2020 and Aug 15, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K043453); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 8, 2025Open, Classified

   Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism.

   Z-0574-2026 · Root cause: Reprocessing Controls · FDA record ↗

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 15, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT FOUR REPROCESSED ACUNAV DIAGNOSTIC ULTRASOUND CATHETERS WERE RECEIVED WET AND TAPED UP. THE WHITE BOXES WERE WET, AND THERE WERE SIGNS OF WATER CONDENSATION INSIDE THE STERILE POUCHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22817114 ↗
• MalfunctionAug 15, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT FOUR REPROCESSED ACUNAV DIAGNOSTIC ULTRASOUND CATHETERS WERE RECEIVED WET AND TAPED UP. THE WHITE BOXES WERE WET, AND THERE WERE SIGNS OF WATER CONDENSATION INSIDE THE STERILE POUCHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816832 ↗
• MalfunctionAug 15, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT FOUR REPROCESSED ACUNAV DIAGNOSTIC ULTRASOUND CATHETERS WERE RECEIVED WET AND TAPED UP. THE WHITE BOXES WERE WET, AND THERE WERE SIGNS OF WATER CONDENSATION INSIDE THE STERILE POUCHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816830 ↗
• MalfunctionAug 15, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT FOUR REPROCESSED ACUNAV DIAGNOSTIC ULTRASOUND CATHETERS WERE RECEIVED WET AND TAPED UP. THE WHITE BOXES WERE WET, AND THERE WERE SIGNS OF WATER CONDENSATION INSIDE THE STERILE POUCHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816829 ↗
• MalfunctionAug 14, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT THE BOX OF THE REPROCESSED ACUNAV DIAGNOSTIC ULTRASOUND CATHETER WAS RECEIVED WITH EXTENSIVE WATER DAMAGE. THE OUTER SHIPPING BOX WAS WET AND THE WHITE PRODUCT BOX INSIDE THE SHIPPING BOX WAS WET AS WELL. UPON INSPECTION OF THE PRODUCT INSIDE THE WET WHITE BOX, WATER DROPLETS WERE OUTSIDE AND INSIDE THE STERILE PACKAGING. THE WHITE BOX WAS VISIBLY DISCOLORED FROM THE WATER/LIQUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22812215 ↗
• MalfunctionNov 20, 2024

  REPROCESSED CATHETER INSERTED INTO BODY, POOR IMAGE QUALITY; CATHETER REMOVED FROM BODY. DIFFERENT NEW CATHETER OPENED, PROBLEM SOLVED. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20733675 ↗
• MalfunctionOct 8, 2024

  REPROCESSED ICE (INTRACARDIAC ECHOCARDIOGRAPHY) CATHETER PLACED IN GROIN ACCESS SITE, STEERING MECHANISM OF CATHETER WOULD NOT TURN, SO ICE CATHETER WAS REMOVED AND REPLACED WITH A NEW CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396977 ↗
• MalfunctionMay 24, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WATCHMAN LEFT ATRIAL APPENDAGE OCCLUSION PROCEDURE WITH A REPROCESSED ACUNAV¿ 8F DIAGNOSTIC ULTRASOUND CATHETER AND INSIDE THE STERILE PACKAGING THERE WAS A HAIR ON THE HUB OF THE CATHETER. THE PACKAGE WAS UNOPENED UNTIL THE PATIENT WAS ON TABLE AND ACCESS WAS MADE. THE CATHETER WAS EXCHANGED TO CONTINUE THE CASE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393111 ↗
• MalfunctionMay 5, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER RIGHT (R-AFL) PROCEDURE WITH A CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM AND FOREIGN MATTER INSIDE THE PACKAGING ISSUE OCCURRED. THE DEVICE HAD SUBSTANCE ON THE CATHETER INSIDE OF THE PACKAGING. THEY REPLACED THE CATHETER. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE PRIMARY PACKAGING BOX WAS OPENED BEFORE THE SURGERY. NO PHYSICAL DAMAGE OBSERVED. THERE WAS NO OTHER ISSUE OBSERVED ON THE PACKAGE OF THE DEVICE (OUTER BOX, TRAY, POUCH). THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR THE FOREIGN MATTER INSIDE THE PACKAGING UNDER THE CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM (STERILMED DEVICE) ON 07-APR-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876248 ↗
• MalfunctionDec 1, 2021Material Twisted/Bent

  FAULTY PRODUCT, BENT CATHETER TIP NOTED UPON OPENING EQUIPMENT.

  Patient problems: Insufficient Information

  MAUDE report 12908000 ↗
• MalfunctionDec 21, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE AND THERE WAS A SMALL HOLE IN THE PACKAGING OF THE ACUNAV CATHETER. THE CATHETER WAS EXCHANGED, AND THE ISSUE WAS RESOLVED. THE CASE CONTINUED WITHOUT ANY FURTHER INCIDENT. ADDITIONAL INFORMATION WAS RECEIVED ON DECEMBER 16, 2020. THE PUNCTURE WAS LOCATED ON THE TOP OF THE PLASTIC POUCH SHEATHING THE ACUNAV. THE HOLE WAS ABOUT THE SIZE OF THE DIAMETER OF A LARGE NEEDLE. IT WAS FOUND AFTER REMOVING THE SURROUNDING BOX. IT IS NOT BELIEVED THE ISSUE COULD HAVE BEEN CAUSED BY SHIPPING AS THE BOX SHOULD HAVE PROTECTED THE PLASTIC. PER THE ADDITIONAL INFORMATION RECEIVED, THIS EVENT HAS BEEN ASSESSED AS MDR REPORTABLE DUE TO THE COMPROMISE IN THE STERILITY OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11047031 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043453. One submission often covers many models, so check the product and lot details in each record.

• Z-0573-2026 · Oct 8, 2025 · Open, Classified
  Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTE
• Z-0551-2009 · Aug 8, 2008 · Terminated
  Cardiac Imaging Catheter Model #'s: ACU08267996 and ACU55790 Intended for intravascular or intracardiac ultrasound imaging in order to provide visualization of vascular anatomy, c