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

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution in the state of Indiana. Quantity: 3738 units Lot/code info: 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

UPC codes

08714729244332

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.