HydroFinity Hydrophilic guidewire — Class I medical device recall Z-1816-2014
Terminated recall by Nitinol Devices and Components, Inc., reported 2014-07-02, distributed nationwide. Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
| Recall number | Z-1816-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nitinol Devices and Components, Inc., Fremont, CA, United States |
| Recall initiated | 2014-05-28 |
| Classified | 2014-06-25 |
| Reported by FDA | 2014-07-02 |
| Terminated | 2015-01-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, DE, FR, GB, IT, NO, SE |
| Model numbers | HPRS35180 |
Product
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 180 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 for recall
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
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-1816-2014. 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.