FDA Device recall Z-0578-2020
Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide
- FDA Device
- Class II
- terminated
- Published 2019-12-04
On 2019-12-04 the FDA classified a Class II recall of Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide by Boston Scientific, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0578-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-24 |
| Published | 2019-12-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Boston Scientific |
| Distribution | US |
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.
Identifiers
| code_info | Lot / GTIN Number / Use By: 1. 23485544 / 8714729939450 / 2021-02-10, 23933296 / 8714729939450 /2021-05-10, 2394788…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0578-2020%22
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