Boston Scientific Corporation Recall 92785
Description: Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheter
Boston Scientific Corporation Recall 92785 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0014-2024 |
| Event ID | 92785 |
| Event Description | Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheter |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of Indiana. |
| Quantity | 17436 units |
| Recall Reason | 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. |
| Device Classification | 20231011 |
| Device 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, 28471407, 28471408, 28471409, 28502673, 28502674, 27558593, 27619799, 28632173, 28632175, 29146651, 27677023, 29146653, 29146654, 27687781, 29146656, 27687782, 29146658, 27696122, 29183520, 29183521, 29183524, 29233903, 29233906, 29233907, 29233909, 29233910, 29233911, 27741722, 29233913, 29271762, 27775275, 29271766, 29271770, 29418790, 27928345, 27936346, 27952564, 27961071, 28239958, 28250416, 28267427, 28275300, 28291108, 28320779, 28320862, 28384664, 28384666, 28502675, 28502676, 28502677, 28502678, 28584616, 28616010, 28632174, 29146650, 29146652, 29146655, 29146657, 29146659, 29183522, 29183523, 29233908, 29233912, 29271763, 29271764, 29418783, 29418789 |
| Center Classification Date | 20231003 |
| Recall Initiation Date | 20230727 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Letter |
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