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Abbott Vascular, Inc. recalls HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588
Recalled January 1, 2014 · FDA recall Z-0558-2014 · Abbott Vascular
Hazard
Abbott Vascular has initiated a recall of the HT Connect Peripheral Guide Wires due to a small number of devices exhibiting partial delamination of the PTFE coating. · FDA Class II
Units
54,895 units total (5,356 units in US)
Sold at
Worldwide Distribution - USA (nationwide) and Internationally to Australia, French Guyana, Macedonia, South Korea, Austria, Germany, Malaysia, Spain, Bahrain, Greece, Martinique, Sweden, Belgium, Hong Kong, Netherlands, Switzerland, Brazil, Indonesia, New Zealand, Taiwan, Bulgaria, Iran, Norway, Thailand, Canada, Iraq, Poland, Turkey, China, Ireland, Portugal, United Arab Emirates, Czech Republic, Italy, Saudi Arabia, United Kingdom, Denmark, Latvia, Singapore, Estonia, Libya, Slovakia, Finland, Lithuania, Slovenia, France, Luxembourg, South Africa.
Description
Abbott Vascular has initiated a recall of the HT Connect Peripheral Guide Wires due to a small number of devices exhibiting partial delamination of the PTFE coating.
Product
HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM 1012589 018 HT CONNECT 300 CM 1012590 018 HT CONNECT FLEX 145 CM 1012591 018 HT CONNECT FLEX 195 CM 1012592 018 HT CONNECT FLEX 300 CM 1012593 018 HT CONNECT 250T 145 CM 1012594 018 HT CONNECT 250T 195 CM 1012595 018 HT CONNECT 250T 300 CM
Manufacturer(s)
Abbott Vascular, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →