FDA-Device2014-01-01Class II
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
Abbott Vascular, Inc.
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.
Sold states
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.
Affected count
54,895 units total (5,356 units in US)
Manufactured in
26531 Ynez Rd, N/A, Temecula, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0558-2014Don't want to check this manually?
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