Boston Scientific Corporation: Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, 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: 17436 units Lot/code info: GTIN 08714729202523, Lot/Batch Numbers: 25651745, 25651749, 25651755, 25761258, 25914835, 25915125, 25964541, 26138808, 26138818, 26138819, 26338718, 26339260, 26339261, 26498387, 26726579, 26726621, 26726622, 26726624, 26746104, 26746105, 25651740, 25651741, 25651742, 25651743, 25651744, 25651746, 25651747, 25651748, 25651750, 25651751, 25651752, 25761255, 25761256, 25761257, 25914833, 25914834, 25914836, 25915124, 25964498, 25964499, 25964540, 25964542, 25964543, 26059648, 26059651, 26059653, 26138719, 26138804, 26138811, 26138815, 26138816, 26138817, 26138840, 26338717, 26338719, 26339262, 26498388, 26498389, 26599638, 26599639, 26599700, 26599701, 26599702, 26599703, 26726620, 26726623, 27016491, 26726625, 27016624, 26746106, 26746107, 26746108, 26746109, 26891771, 26891772, 26891773, 27007548, 27007549, 27016490, 27042423, 27121007, 27121008, 27136897, 27136898, 27152183, 27203534, 27247812, 27262276, 27265388, 27265390, 27265391, 27265393, 27323834, 27327741, 27367348, 27367349, 27379023, 27420627, 27420628, 27431146, 27450919, 27504209, 27516636, 27558591, 27558592, 27558594, 27611878, 27619841, 27627222, 27627223, 27677022, 27247813, 27262277, 27696121, 27265392, 27703701, 27741721, 27747953, 27767764, 27327740, 27928346, 27936345, 27972713, 27972714, 28007177, 28239957, 27386633, 28242517, 28242518, 27386634, 28250417, 28260600, 28260601, 28267426, 27420629, 28275299, 28283283, 28283284, 28291109, 27450920, 28320860, 28320861, 28384663, 27459237, 28384665, 28471406,

UPC codes

08714729202523

Source

Official record: FDA (Device enforcement) ↗

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