medical Class II Updated 2023-10-11

Boston Scientific Corporation recalls Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog

Recalled Product

Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, 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 08714729202516, Lot/Batch Numbers: 25761345, 26059398, 26138707, 26599635, 26599636, 25761344, 25964138, 25964139, 25964480, 25964481, 25964482, 26059399, 26130252, 26130253, 26138708, 26277183, 26599634, 26599637, 26746100, 26746101, 26746102, 26746103, 26891769, 26891770, 26997421, 26997422, 27129310, 27129311, 27144692, 27779956, 27779958, 28384662, 28502672, 28676780, 28832480, 28832482, 28886617, 28886618, 28886619, 28955942, 27144691, 27269744, 27585414, 28007176, 28676579, 28886800
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