Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1582-2022

August 09, 2022

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 90735
Status
Ongoing
Classification
Class II
Quantity
184 devices (UPDATED)
Official record key
device-enforcement:Z-1582-2022

Official wording

Reason: 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.

Code information: UDI/DI 08714729202486, Lot/Batch 27339850, Use By 2021-05-18, and UPDATE: Lot/Batch 29308869, Use By 4/27/2025.

Distribution pattern: International distribution in the countries of Greece, France, Germany, Italy, Brazil and South Korea. UPDATE: The devices were also distributed to Russia. There was no U.S. distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.