AquaLiner Hydrophilic Guidewire 0 — Class II medical device recall Z-0134-2013
Terminated recall by Nipro Medical Corporation, reported 2012-10-31, distributed in NY. Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain
| Recall number | Z-0134-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nipro Medical Corporation, Miami, FL, United States |
| Recall initiated | 2012-07-27 |
| Classified | 2012-10-25 |
| Reported by FDA | 2012-10-31 |
| Terminated | 2013-05-25 |
| Distributed | NY |
| Countries outside the US | AR, BR, CL, CO, DE, EC, ES, MX, PA, PE |
| Quantity | 400 |
| Lot numbers | 11I27, 12B13 |
Product
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0134-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.