Recall Z-1817-2014— Nitinol Devices and Components, Inc.
Class I · Terminated
Class I FDA medical device recall by Nitinol Devices and Components, Inc., initiated 2014-05-28, terminated 2015-01-13. It names one FDA 510(k) clearance: K121398. Product: HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard 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..
- Recalling firm
- Nitinol Devices and Components, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-05-28
- Terminated
- 2015-01-13
- Firm location
- Fremont, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard 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 for recall
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Data sourced from openFDA. This site is unofficial and independent of the FDA.