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Recall Observatory FDA recall evidence

Device product

Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

Z-0010-2024

July 27, 2023

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 92785
Status
Ongoing
Classification
Class II
Quantity
4426 units
Official record key
device-enforcement:Z-0010-2024

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 0871472920247, Lot/Batch Numbers: 26034355, 26034358, 25761346, 26034356, 26034832, 26034833, 26277184, 26277185, 26599620, 26599621, 26599624, 26745648, 26745649, 26891296, 27081941, 27081942, 27081943, 27103346, 27645560, 27696357, 27754497, 27779955, 27780469, 27996306, 28049141, 28384636, 28384637, 28502666, 28502667, 28676577, 28676578, 28841172, 28841173, 28841174, 28841175, 28841176, 28910752, 28910754, 26277186, 26411753, 26599622, 26599623, 26745647, 26891297, 26891498, 27081944, 27081945, 28841177, 28955941

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.