Device product
Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 G14260
Z-0961-2020
Product summary
- Firm
- Cook Inc.
- Event
- Event 82026
- Status
- Terminated
- Classification
- Class II
- Quantity
- 146
- Official record key
device-enforcement:Z-0961-2020
Official wording
Reason: The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Code information: 7875295 8481133 NS8481135
Distribution pattern: Domestic distribution to nationwide US. Foreign distribution to Australia, Belgium, Bolivia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, French Polynesia, Germany, Guatemala, Honduras, Hungary, India, Ireland, Italy, Japan, Korea, Luxembourg, Malaysia, Malta, Mexico, Mongolia, Netherlands, New Caledonia, New Zealand, Oman, Panama, Paraguay, Poland, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan, Trinidad and Tobago, United Arab Emirates, and the United Kingdom.
Derived failure modes
-
Unknown
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.