NA ACU10043342Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888551004718), received between Jun 13, 2023 and Dec 15, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (2 reports).

3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2025Tear, Rip or Hole in Device Packaging; Material Twisted/Bent; Packaging Problem; Tear, Rip or Hole in Device Packaging; Material Twisted/Bent; Packaging Problem

  IT WAS REPORTED THAT A REPROCESSED ACUSON ACUNAV¿ ULTRASOUND CATHETER WAS RECEIVED DAMAGED THROUGH SHIPPING. THE EXTERIOR, INTERIOR AND INTERNAL STERILE PACKAGING OF THE CATHETER AND BOX WERE ALL DAMAGED WHEN RECEIVED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION ON THIS COMPLAINT. HOWEVER, IT HAS NOT BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803039 ↗
• MalfunctionJun 13, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING PRE-OP, A REPROCESSED CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 10FR HAD A RIP INSIDE OF THE INNER PACKAGING. THE BOX WAS OPENED BEFORE THE SURGERY AND THE ISSUE WAS NOTICED WHEN BEING UNPACKED FOR THE FIRST TIME. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17121412 ↗

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-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