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Recall Observatory FDA recall evidence

Device product

Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac guide catheter

Z-0017-2024

July 27, 2023

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 92785
Status
Ongoing
Classification
Class II
Quantity
1728 units
Official record key
device-enforcement:Z-0017-2024

Official wording

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.

Code information: GTIN 08714729244295, Lot/Batch Numbers: 26138711, 26276489, 26276490, 26590803, 26746110, 26891804, 26891805, 27162093, 27162094, 27203536, 27431372, 26059693, 26138710, 26276491, 26590802, 26746111, 27203537, 27219436, 27431373, 27526941, 27801040, 28811942, 28811943

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.