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Recall Observatory FDA recall evidence

Device product

Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac guide catheter

Z-0020-2024

July 27, 2023

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 92785
Status
Ongoing
Classification
Class II
Quantity
3738 units
Official record key
device-enforcement:Z-0020-2024

Official wording

Reason: Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Code information: GTIN 08714729244332, Lot/Batch Numbers: 26059697, 26339267, 26339269, 26590800, 26746116, 26891817, 26891818, 27065537, 27288435, 27535145, 27592321, 28132917, 28384670, 25715225, 25715226, 26059695, 26339266, 26339268, 26498391, 26590801, 26746114, 26746115, 26891816, 28632177, 27081948, 27254932, 27280217, 27435623, 27558595, 27592320, 27767765, 27824570, 28115146, 28738180, 28384671, 28632176, 28632178, 28632179, 28737899, 28738181, 28886805, 28886806, 28886807, 29113162, 28795500

Distribution pattern: US Nationwide distribution in the state of Indiana.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.