CLASS I Device recall · Reported 2 Jul 2014 · FDA Enforcement Report
HydroFinity Hydrophilic guidewire recalled
Nitinol Devices and Components is recalling HydroFinity Hydrophilic guidewire, distributed nationwide in the US. The recall was initiated on 28 May 2014 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1823-2014
- FDA event ID
- 68419
- Recalling firm
- Nitinol Devices and Components, Fremont, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 28 May 2014
- FDA classified
- 25 Jun 2014
- Reported
- 2 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 28 May 2014 | Recall initiated by company | |
| 25 Jun 2014 | Classified by FDA | +28 days |
| 2 Jul 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.
Questions about this recall
Is HydroFinity Hydrophilic guidewire recalled?
Yes. Nitinol Devices and Components recalled HydroFinity Hydrophilic guidewire on 28 May 2014. The recall is Class I and its status is Terminated. Recall number Z-1823-2014.
Why was it recalled?
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Which lots are affected?
Model HPSS35260- all lots.
Where was it sold?
Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Nitinol Devices and Components
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | HydroFinity Hydrophilic guidewire recalled | Nitinol Devices and Components | Sterility | Nationwide |
| Device | CLASS I | HydroFinity Hydrophilic guidewire recalled | Nitinol Devices and Components | Sterility | Nationwide |
| Device | CLASS I | HydroFinity Hydrophilic guidewire;Nitinol Guidewire recalled | Nitinol Devices and Components | Sterility | Nationwide |
| Device | CLASS I | HydroFinity Hydrophilic guidewire recalled | Nitinol Devices and Components | Sterility | Nationwide |
| Device | CLASS I | HydroFinity Hydrophilic guidewire recalled | Nitinol Devices and Components | Sterility | Nationwide |
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