FDA Device recall Z-0138-2013
AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular
- FDA Device
- Class II
- terminated
- Published 2012-10-31
On 2012-10-31 the FDA classified a Class II recall of AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular by Nipro Medical, citing nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0138-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-27 |
| Published | 2012-10-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nipro Medical |
| Distribution | NY |
Product
AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
Reason
Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.
Identifiers
| code_info | Item Code: AL+60000302 Lot #: 12D05 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0138-2013%22
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