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Cook Inc. recalls Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the de
Recalled March 2, 2016 · FDA recall Z-0798-2016 · Cook
Hazard
Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result. Recall expanded 10/07/2015 to include additional catheters. · FDA Class I
Units
9519
Sold at
Worldwide Distribution - US (nationwide including Puerto Rico and US Virgin Islands), Algeria, Antigua, Armenia, Austria, Australia, Bahamas, Belgium, Bangladesh, Bulgaria, Bahrain, Brazil, Brunei Darussalam, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Ghana, Great Britain, Greece Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kuwait, Kazakhstan, Republic of Korea, Kuwait, Lebanon, Lithuania, Luxemburg, Latvia, Libya, Macau, Malaysia, Malta, Martinique, Mexico, Mongolia, Morocco, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sweden, Switzerland, Spain, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
Description
Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result. Recall expanded 10/07/2015 to include additional catheters.
Product
Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.
Manufacturer(s)
Cook Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →