medical Class II Updated 2023-10-11

Boston Scientific Corporation recalls Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog

Recalled Product

Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, 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 08714729244301, Lot/Batch Numbers: 27241919, 27516638, 27780467, 27780470, 28065090, 26138318, 26891812, 28676781, 28595471, 28676782, 28886804, 28910751
View official government recall

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