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Recall Observatory FDA recall evidence

Device product

Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590

Z-0959-2020

January 04, 2019

Class II

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

    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.