Boston Scientific Corporation: Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution in the state of Indiana. Quantity: 4426 units 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

UPC codes

0871472920247

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.