Recall Z-0310-2017— Micro Therapeutics Inc, Dba Ev3 Neurovascular
Class I · Terminated
Class I FDA medical device recall by Micro Therapeutics Inc, Dba Ev3 Neurovascular, initiated 2016-10-05, terminated 2017-10-11. FDA's recall record names no specific 510(k) clearance for this event. Product: X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 103-0602-350V10 103-0601-300V03 103-0602-300V02 103-0601-300V06 103-0602-300v06 103-0601-300V10 103-0602-300V09 103-0601-300V11 103-0602-300V10 103-0601-350 103-0602-350 103-0601-350V01 103-0602-350V01 103-0601-350V06 103-0602-350V02. Reason: Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream..
- Recalling firm
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2016-10-05
- Terminated
- 2017-10-11
- Firm location
- Irvine, CA, United States
Product description
X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 103-0602-350V10 103-0601-300V03 103-0602-300V02 103-0601-300V06 103-0602-300v06 103-0601-300V10 103-0602-300V09 103-0601-300V11 103-0602-300V10 103-0601-350 103-0602-350 103-0601-350V01 103-0602-350V01 103-0601-350V06 103-0602-350V02
Reason for recall
Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
Data sourced from openFDA. This site is unofficial and independent of the FDA.