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.
Enforcement
- Recall Number
- Z-1816-2014
- Event ID
- 68419
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Nitinol Devices and Components, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 2, 2014
- Initiation Date
- May 28, 2014
- Classification Date
- June 25, 2014
- Termination Date
- January 13, 2015
- Address
- 47533 Westinghouse Dr, N/A, Fremont, CA, 94539-7463, United States
Description
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.
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Model HPRS35180- all lots.
Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.
8485 in US, 9595 - ROW - total, all models