Home / Recalls / Cook Inc. / Z-2623-2016

Z-2623-2016 Class II Terminated

Recalled by Cook Inc. — Bloomington, IN

FDA device recall Z-2623-2016 was initiated by Cook Inc. on Apr 15, 2016 and is designated Class II. Reason for recall: Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading… The recall status is terminated (terminated Aug 4, 2017). Affected quantity: 3,425.

Recall Details

Product Type: Devices
Report Date: Aug 31, 2016
Initiation Date: Apr 15, 2016
Termination Date: Aug 4, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,425

Product Description

White Lumax Guiding Coaxial Catheter Catheter, Percutaneous Intended for the delivery of angioplasty balloons and other types of interventional devices.

Reason for Recall

Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

Distribution Pattern

Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.

Code Information

All Lots. Catalog/product number; Global/order number LMGRF-7.0C-80-MPA-PULM G11164

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2623-2016
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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