Device 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.
Z-1816-2014
Product summary
- Event
- Event 68419
- Status
- Terminated
- Classification
- Class I
- Quantity
- 8485 in US, 9595 - ROW - total, all models
- Official record key
device-enforcement:Z-1816-2014
Official wording
Reason: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Code information: Model HPRS35180- all lots.
Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.
Derived failure modes
-
Unknown
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.