FDA Device recall Z-0970-2020
Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844
- FDA Device
- Class II
- terminated
- Published 2020-02-12
On 2020-02-12 the FDA classified a Class II recall of Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844 by Cook, citing the wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0970-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-04 |
| Published | 2020-02-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cook |
| Distribution | US |
Product
Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844
Reason
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Identifiers
| code_info | 8494465 8513227 8537103 8537104 8552050 8552051 8567256 8576963 8632766 8639366 8659206 8683459 8754089 NS8513228 |
|---|
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-0970-2020%22
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