• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall HT Connect Peripheral Guide Wire

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall HT Connect Peripheral Guide Wire see related information
Date Posted December 20, 2013
Recall Status1 Terminated 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
-
-