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Recall Observatory FDA recall evidence

Device product

Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493933515060, 6F; 2. REF/Catalog No H7493933515070, 7F.

Z-0578-2020

October 24, 2019

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 84152
Status
Terminated
Classification
Class II
Quantity
14,145 devices total
Official record key
device-enforcement:Z-0578-2020

Official wording

Reason: Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.

Code information: Lot / GTIN Number / Use By: 1. 23485544 / 8714729939450 / 2021-02-10, 23933296 / 8714729939450 /2021-05-10, 23947883 / 8714729939450 / 2021-05-12, 24137846 / 8714729939450 / 2021-06-17. 2. Lots: 21305995 / 8714729939474 / 2019-09-25, 24201181 / 8714729939474 / 2021-06-30.

Distribution pattern: Nationwide including Washington D.C. and Puerto Rico. OUS to include Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.