medical Class II Updated 2023-10-11

Boston Scientific Corporation recalls Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog

Recalled Product

Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, 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 08714729283515, Lot/Batch Numbers: 25651754, 25651753, 25761245, 26059691, 26409982, 26599707, 27219434 ****recall letter has more lot numbers****
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