—#202573

Product

Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Employee error

Action the firm took

Stryker issued an URGENT: MEDICAL DEVICE VOLUNTARY Recall notice to it consignees on 07/31/2023. The notice explained the issue, potential risk, and required the following actions be taken: 1. Immediately check your internal inventory for affected devices. 2. Segregate the affected units in a secure location for return to Stryker. 3. Circulate this Recall-Removal notice internally to all interested/affected parties. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. 5. Inform Stryker if any of the subject devices have been distributed to other organizations. If yes, provide contact details so that Stryker can inform the recipients appropriately.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern: US Nationwide distribution in the state of Indiana.

Timeline

Recall initiated: 2023-07-27
Posted by FDA: 2023-10-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #202573. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.