FDA Device recall Z-1823-2014
HydroFinity Hydrophilic guidewire
- FDA Device
- Class I
- terminated
- Published 2014-07-02
On 2014-07-02 the FDA classified a Class I recall of HydroFinity Hydrophilic guidewire by Nitinol Devices And Components, citing reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1823-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-05-28 |
| Published | 2014-07-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nitinol Devices And Components |
| Distribution | US |
Product
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Straight Tip, 260 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA; Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.
Reason
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Identifiers
| code_info | Model HPSS35260- all lots. |
|---|
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-1823-2014%22
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