Z-0011-2024 Class II Ongoing
FDA device recall Z-0011-2024 was initiated by Boston Scientific Corporation on Jul 27, 2023 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 8475 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 11, 2023
- Initiation Date
- Jul 27, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8475 units
Product Description
Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter
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 Pattern
US Nationwide distribution in the state of Indiana.
Code Information
GTIN 08714729202486, Lot/Batch Numbers: 25651714, 25651716, 26034835, 26034836, 26034839, 25651712, 25651713, 25651715, 25651717, 25651718, 25651719, 26034834, 26034837, 26034838, 26059640, 26059641, 26138712, 26338710, 26338711, 26338712, 26338713, 26338714, 26338715, 26599628, 26599629, 26599632, 26599633, 26745651, 26745652, 26745653, 26745654, 26745655, 26745656, 26891494, 26891499, 26891761, 26891762, 26891763, 26891764, 26891766, 26891767, 27081946, 27162090, 27162091, 27162092, 27184893, 27184895, 27192450, 27192451, 27347761, 27386636, 27516584, 27568838, 27568839, 27654466, 27661667, 27669282, 27728491, 27894535, 27943983, 28320869, 28320870, 28320871, 28320872, 28384638, 28384639, 28384660, 26599625, 28471411, 28502668, 28502669, 26599626, 28676785, 28676786, 28676787, 28676788, 29308869, 26599627, 29308874, 26599630, 26599631, 26745650, 26891492, 26891493, 26891495, 26891760, 26891765, 27081947, 27367346, 27367347, 27661666, 27669283, 27735227, 27735228, 27894534, 28471410, 28502670, 29308872
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0011-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026