Reported Aug 31, 2022 · Ongoing

Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440

Boston Scientific Corporation

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: Boston Scientific Corporation · 1 Scimed Pl · Maple Grove, MN · 55311-1565

Is this the product you have?

    • Boston Scientific Guider Softip XF
    • 40 XF
    • 8F
    • Guide Catheter
    • REF H965100440
Lot codes and dates
    • UDI/DI 08714729202486
    • Lot/Batch 27339850
    • Use By 2021-05-18
  • and UPDATE
    • Lot/Batch 29308869
    • Use By 4/27/2025
Amount recalled
184 devices (UPDATED)

Why it was recalled

The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.

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

Data as of Sep 19, 6:55 PM UTC

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