Reported Jun 22, 2022 · Terminated

Philips OmniWire Pressure guide wire REF 89185J PN 300000252891

Volcano Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Volcano Corp · 3721 Valley Centre Dr Ste 500 · San Diego, CA · 92130-3328

Is this the product you have?

  • Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Lot codes and dates
  • Model Number89185J
  • Part Number300000252891
  • UDI Code(01)00845225003050(11)220309(17)250309(10)0302535768
  • Serial Numbers
    • 37583
    • 37586
    • 37590
    • 37598
    • 37612
    • 37648
    • 37655
    • 37692
    • 37694
    • 37709
    • 37719
Amount recalled
11 devices

Where it was sold

Why it was recalled

Due to a potential failed sterilization process.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 23, 2024 · Data as of Sep 19, 4:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.