medical Class II Updated 2023-10-11

Boston Scientific Corporation recalls Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog

Recalled Product

Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, 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 08714729202462, Lot/Batch Numbers: 25651700, 25651701, 25651702, 25651703, 25651704, 25651705, 25651706, 25651708, 25651709, 25651710, 25651711, 25761340, 25761341, 25761342, 25761343, 25964544, 25964545, 25964546, 25964547, 26019585, 26019586, 26034354, 26034357, 26138841, 26138842, 26138844, 26338705, 26338706, 26338707, 26338708, 26411750, 26411751, 26411752, 26745645, 26745646, 26891497, 27269743, 27654465, 27696356, 27703700, 27809357, 27996305, 26019584, 28107548, 28158175, 26019587, 28502663, 28502664, 28502665, 28584619, 28737891, 28737892, 28737893, 28795036, 28886611, 28886612, 29112775, 29112777, 26138843, 26138845, 26338704, 26338709, 26498390, 26891295, 26891496, 27103345, 27762224, 27809358, 28091480, 28384635, 28502662, 28795035, 28795037
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