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Boston Scientific Corporation Recall 90735

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

Boston Scientific Corporation Recall 90735 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1582-2022
Event ID90735
Event DescriptionBoston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
Product TypeDevices
DistributionInternational distribution in the countries of Greece, France, Germany, Italy, Brazil and South Korea
Quantity94 devices
Recall ReasonThe 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.
Device Classification20220831
Device Code InfoUDI/DI 08714729202486, Lot/Batch 27339850, Use By 2021-05-18
Center Classification Date20220825
Recall Initiation Date20220809
Recalling FirmBoston Scientific Corporation
Initial Notification Letter
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