NA ACU10135910Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10888551004725), received between Dec 5, 2019 and Nov 21, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (3 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-0573-2026 · Root cause: Reprocessing Controls · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION WITH A REPROCESSED ACUNAV¿ 8F DIAGNOSTIC ULTRASOUND CATHETER AND THE PATIENT EXPERIENCED AN INFECTION POST ABLATION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 20753697 ↗
• MalfunctionMay 30, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT WHEN SETTING UP FOR THE ATRIAL FIBRILLATION PROCEDURE, THE INTERNAL PACKAGING OF THE REPROCESSED ACUNAV¿ 8F DIAGNOSTIC ULTRASOUND CATHETER WAS PUNCTURED, CAUSING THE CATHETER NOT TO BE STERILE. THE CATHETER WAS REPLACED, AND THE PROCEDURE CONTINUED. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19426341 ↗
• InjuryApr 8, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WATCHMAN PROCEDURE WITH A REPROCESSED ACUSON ACUNAV IMAGING CATHETER AND THE PATIENT EXPERIENCED CARDIAC PERFORATION. A PERICARDIAL EFFUSION WAS DISCOVERED AND CONFIRMED ON INTRACARDIAC ECHOCARDIOGRAM. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND AUTORETRANSFUSION FROM PERICARDIOCENTESIS. IT IS UNKNOWN HOW MUCH FLUID WAS REMOVED. THE PATIENT WENT INTO SURGERY AND THE CARDIOVASCULAR SURGEON CLOSED THE PERFORATION IN THE RIGHT VENTRICLE (RV). PATIENT CONDITION HAS IMPROVED. THE PHYSICIAN BELIEVED THE ISSUE TO BE DUE TO THE ACUNAV CATHETER. ANOTHER PHYSICIAN, WHO DID NOT PERFORM THE WATCHMAN PROCEDURE, SAID THE ONLY CAUSE OF THE PERFORATION COULD HAVE BEEN THE ACUNAV SINCE IT WAS THE ONLY THING IN THAT WAS EVER IN THE RV.

  Patient problems: Cardiac Perforation

  MAUDE report 19060876 ↗
• MalfunctionAug 24, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION PROCEDURE, THE REPROCESSED ACUNAV¿ CATHETER PACKAGING WAS PUNCTURED BY A HARD PLASTIC STRAW-LIKE PART OF THE PACKAGING, AND THE STERILIZATION WAS COMPROMISED. THE BOX DID NOT LOOK DAMAGED. EVERYTHING ELSE IN THE BOX WAS OKAY. THE CATHETER WAS REPLACED, AND THE ISSUE WAS RESOLVED. THE CASE CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17619475 ↗
• MalfunctionSep 8, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM AND AN OPEN POUCH SEAL ISSUE OCCURRED. THE STERILE PACKAGING HAD A HOLE IN THE PACKAGING. THE CATHETER WAS REPLACED BEFORE BEING PLACED ON THE TABLE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15384530 ↗
• MalfunctionDec 5, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A REPROCESSED ACUNAV DIAGNOSTIC ULTRASOUND CATHETER AND THE STERILITY WAS COMPROMISED. DURING PRE-OP SET UP, WHEN THE CATHETER BOX WAS OPENED, THE INSIDE PACKAGE WAS BENT, THE CATHETER WAS BENT, AND THE PACKAGE STERILITY WAS COMPROMISED. CATHETER WAS NEVER USED AND DID NOT COME IN CONTACT WITH THE PATIENT AS IT WAS DAMAGED AND NO LONGER STERILE. AN ALTERNATIVE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE INTENT OF THE PROCEDURE WAS NOT ALTERED DUE TO THIS EVENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9418690 ↗

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-0574-2026 · Oct 8, 2025 · Open, Classified
  Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135936 Sof
• 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