Skip to content
Recall Observatory FDA recall evidence

Device product

Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823

Z-0972-2020

January 04, 2019

Class II

Product summary

Firm
Cook Inc.
Event
Event 82026
Status
Terminated
Classification
Class II
Quantity
13388 total
Official record key
device-enforcement:Z-0972-2020

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: 8011030 8033568 8063430 8063431 8150491 8417631 8417632 8587162 8587163 8590532 8590533 7990830 8003084 8033571 8063428 8590520 8590522 8629475 NS8629473

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

    reason.no_named_rule · v1.0.0

    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.