Recall Z-0558-2014— Abbott Vascular, Inc.
Class II · Terminated
Class II FDA medical device recall by Abbott Vascular, Inc., initiated 2013-11-25, terminated 2014-07-14. FDA's recall record names no specific 510(k) clearance for this event. 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. 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..
- Recalling firm
- Abbott Vascular, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-25
- Terminated
- 2014-07-14
- Firm location
- Temecula, CA, United States
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.