Boston Scientific Corporation: Medical Device Recall in 2024 - (Recall #: Z-1653-2024)

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3.5 (5PK), REF H74908526212; cardiac catheter

Class I

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

UDI/DI 08714729187813, Batch Numbers: 60423725, 60438648, 60449984, 60474078, 60488293, 60507284, 60427729, 60438649, 60453725, 60474079, 60490173, 60507287, 60427730, 60440943, 60453726, 60474080, 60490174, 60507479, 60427731, 60440944, 60461414, 60475372, 60490175, 60507660, 60427732, 60440945, 60461429, 60475376, 60490176, 60507661, 60427733, 60440946, 60536188, 60475377, 60490177, 60507662, 60427734, 60440947, 60463596, 60475378, 60490178, 60507663, 60430886, 60443002, 60463598, 60475379, 60490179, 60511641, 60430922, 60443027, 60463962, 60476443, 60491458, 60511642, 60430923, 60443028, 60463972, 60476444, 60491465, 60511643, 60430925, 60443029, 60463973, 60477294, 60491466, 60511644, 60432701, 60443030, 60464490, 60477295, 60491467, 60515578, 60432702, 60443031, 60464491, 60477296, 60493944, 60515579, 60432716, 60443897, 60467016, 60477297, 60495540, 60515580, 60432719, 60443898, 60467017, 60479452, 60495541, 60517602, 60433872, 60443899, 60467018, 60479453, 60495542, 60517603, 60433875, 60443900, 60467019, 60479454, 60495543, 60517604, 60433885, 60443901, 60467020, 60479455, 60495544, 60517607, 60433886, 60443902, 60469093, 60481591, 60495545, 60522510

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

Voluntary: Firm initiated