Device product
Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590
Z-0959-2020
Product summary
- Firm
- Cook Inc.
- Event
- Event 82026
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1079
- Official record key
device-enforcement:Z-0959-2020
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: 7832513 7832514 8062406 8062407 8065988 8065989 8065992 8404354 8404355 8547811 8069648
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.