medical Class II Updated 2023-10-11

Boston Scientific Corporation recalls Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog

Recalled Product

Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, 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 08714729283508, Lot/Batch Numbers: 26277195, 26891778, 25715235, 25715236, 25761247, 25761248, 26059690, 26277194, 26599706, 27170548, 27444248, 27516585, 28057178, 28584686, 28595475, 28811944
View official government recall

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