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N/A (REF 10439011)Recalls & reported problems

Stryker Sustainability Solutions, Inc. · Diagnostic Ultrasound Catheter, 8F · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885825020927), received between Dec 6, 2019 and Dec 6, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Poor Quality Image” (1 report).

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

  • Poor Quality Image1

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.

  • InjuryDec 6, 2019Poor Quality Image; Poor Quality Image

    IT WAS REPORTED THAT THE DIAGNOSTIC ULTRASOUND CATHETER IMAGE WAS VERY POOR AND GRAINY. A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY AND THE EXTENDED PROCEDURE TIME WAS TEN MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9433401 ↗

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.