medical Class II Updated 2023-10-11

Boston Scientific Corporation recalls Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog

Recalled Product

Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN 08714729202509, Lot/Batch Numbers: 26059397, 26338716, 25822912, 25822914, 25822915, 25822916, 26059642, 26584704, 26585219, 26745658, 26745659, 26891768, 27177893, 27412261, 27504202, 27568860, 27754498, 27816607, 28100259, 28384661, 28502671, 28737894, 28737895, 26745657, 27177892, 28320873, 28584618, 28795038
View official government recall

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