Device product
Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844
Z-0970-2020
Product summary
- Firm
- Cook Inc.
- Event
- Event 82026
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13388 total
- Official record key
device-enforcement:Z-0970-2020
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: 8494465 8513227 8537103 8537104 8552050 8552051 8567256 8576963 8632766 8639366 8659206 8683459 8754089 NS8513228
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.