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NA R10135936Recalls & reported problems

Sterilmed, Inc. · REPROCESS ACUNAV 8F-90 SMS · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888551044349), received between Aug 20, 2019 and Aug 20, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

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

Most reported problems

Device problems

  • Delivered as Unsterile Product1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 20, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A REPROCESSED ACUNAV 8F-90 SMS CATHETER, AND THE STERILE PACKAGING FOR THE CATHETER WAS DAMAGED, AS THERE WAS SOME TEARING AND THE PACKAGE WAS OPEN. IN ADDITION, THE CATHETER SHAFT WAS ALSO BENT OUT OF THE PACKAGING. THERE WERE NO EXPOSED WIRES. THE CATHETER WAS REPLACED, AND THE ISSUE RESOLVED. THERE WAS NO PATIENT CONTACT WITH THE DEVICE AND NO PATIENT CONSEQUENCE. THE PROCEDURE WAS NOT ALTERED DUE TO THIS ISSUE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8913239 ↗

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-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

Other Reprocessed intravascular ultrasound catheter devices

All Reprocessed intravascular ultrasound catheter devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.