medical Class II Updated 2023-10-11

Boston Scientific Corporation recalls Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog

Recalled Product

Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, 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 0871472920247, Lot/Batch Numbers: 26034355, 26034358, 25761346, 26034356, 26034832, 26034833, 26277184, 26277185, 26599620, 26599621, 26599624, 26745648, 26745649, 26891296, 27081941, 27081942, 27081943, 27103346, 27645560, 27696357, 27754497, 27779955, 27780469, 27996306, 28049141, 28384636, 28384637, 28502666, 28502667, 28676577, 28676578, 28841172, 28841173, 28841174, 28841175, 28841176, 28910752, 28910754, 26277186, 26411753, 26599622, 26599623, 26745647, 26891297, 26891498, 27081944, 27081945, 28841177, 28955941
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