Recall Z-0578-2020— Boston Scientific Corporation

Name: FDA recall Z-0578-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-24

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2019-10-24, terminated 2023-03-20. It names one FDA 510(k) clearance: K163314. 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.. 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..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2019-10-24
Terminated: 2023-03-20
Firm location: Maple Grove, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K163314 — Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension CatheterBoston Scientific Corporation·cleared 2017-03-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.