medical Class II Updated 2023-10-11

Boston Scientific Corporation recalls Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog

Recalled Product

Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, 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 08714729244356, Lot/Batch Numbers: 26277188, 26599713, 26709826, 27170547, 27203658, 27339851, 27535146, 27728492, 27902047, 28320867, 28564218, 28616007, 28632345, 26138706, 26277189, 26411756, 26411757, 26599714, 26599715, 26709827, 26746119, 26746120, 26891840, 26891841, 26984254, 27254933, 27379026, 27379027, 27558597, 27645561, 27782880, 27980980, 27988374, 28320864, 28320865, 28320866, 28564219, 28564380, 28584613, 28616008, 28632340, 28632341, 28632342, 29513117
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