Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Confluent Medical TechnologiesLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Nitinol Devices and Components with 12 device recalls. The most recent is a device recall dated May 28, 2014: HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. ….
| May 28, 2014 | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 150 CM LeClass I · Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. | Device recalls |
| May 28, 2014 | HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; ManufaClass I · Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. | Device recalls |
| May 28, 2014 | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.Nitinol Guidewire with Hydrophilic Coating, Sterile. Class I · Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. | Device recalls |
| May 28, 2014 | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 180 CM LengClass I · Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. | Device recalls |
| May 28, 2014 | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 150 CM Length;Class I · Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. | Device recalls |
| May 28, 2014 | HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 180 CM Length; Class I · Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. | Device recalls |
| May 28, 2014 | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 150 CM LengClass I · Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. | Device recalls |
| May 28, 2014 | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 260 CM LengClass I · Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. | Device recalls |
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