Reported Oct 16, 2019 · Terminated

Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #:…

Stryker Neurovascular

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: Stryker Neurovascular · 47900 Bayside Pkwy · Fremont, CA · 94538-6515

Is this the product you have?

    • Stryker Neurovascular
    • Merci 9F
    • 80cm
    • Balloon Guide Catheter
    • REF 90077
    • CE 0459
    • UPN Product No. 90077
    • UDI #: (01)00815742000771
Lot codes and dates
  • Lot number 0000010779; This lot was not distributed within the US
Amount recalled
190 catheter guides

Why it was recalled

Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging

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 Aug 3, 2020 · Data as of Sep 19, 5:28 PM UTC

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