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U.S. Department of Health and Human Services

Class 2 Device Recall HT Connect Peripheral Guide Wire

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  Class 2 Device Recall HT Connect Peripheral Guide Wire see related information
Date Initiated by Firm November 25, 2013
Date Posting Updated December 20, 2013
Recall Status1 Terminated 3 on July 14, 2014
Recall Number Z-0558-2014
Recall Event ID 66971
Product Classification Wire, guide, catheter - Product Code DQX
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
Code Information 2, 1012594 90021264, 1012594 90021265, 1012594 90021376, 1012594 90021504, 1012594 90021505, 1012595 10087178, 1012595 10101124, 1012595 10118330, 1012595 10122330, 1012595 10148523, 1012595 10171694, 1012595 10181962, 1012595 10193576, 1012595 10194668, 1012595 10194670, 1012595 10198921, 1012595 10198922, 1012595 10198929, 1012595 10220286, 1012595 10220319, 1012595 10220933, 1012595 10220934, 1012595 10220940, 1012595 10232265, 1012595 10232266, 1012595 10232267, 1012595 10252332, 1012595 10265828, 1012595 10309229, 1012595 10309243, 1012595 10311457, 1012595 90020544, 1012595 90020745, 1012595 90021059, 1012595 90021077, 1012595 90021274, 1012595 90021275, 1012595 90021377, 1012595 90021378, 1012595 90021401, 1012595 90021402, 1012595 90021506, 1012595 90021571
Recalling Firm/
Manufacturer
Abbott Vascular, Inc.
26531 Ynez Rd
Temecula CA 92591-4630
For Additional Information Contact
951-914-2400
Manufacturer Reason
for Recall
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 Determined
Cause 2
Pending
Action Abbott Vascular sent an Urgent Device Recall letter dated November A recall communication letter dated November 25, 2013, to all affected customers. The letter informed customers of the problems identified and the actions to be taken. The letter informs the customers of the 9 part numbers and 9 description of the products. Abbott Vascular is instructing the customers that the returned products will be replaced with similar products pending availability. Abbott Vascular has attached a customer response form for customers along with the customer notification letter. For questions regarding this recall call 951-914-2400.
Quantity in Commerce 54,895 units total (5,356 units in US)
Distribution 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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