Recall Z-0558-2014 ยท DQX Wire, Guide, Catheter
Abbott Vascular, Inc.
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 101
| Date | Dec 20, 2013 (initiated Nov 25, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 t |
| Quantity | 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, Tha |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.