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 XF40 XF8FGuide CatheterREF H965100440
- Lot codes and dates
UDI/DI 08714729202486Lot/Batch 27339850Use By 2021-05-18
- and UPDATE
Lot/Batch 29308869Use 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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