Recall Z-2471-2012— Micro Therapeutics Inc, Dba Ev3 Neurovascular
Class II · Terminated
Class II FDA medical device recall by Micro Therapeutics Inc, Dba Ev3 Neurovascular, initiated 2011-09-23, terminated 2012-09-28. It names one FDA 510(k) clearance: K024118. Product: UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.. Reason: The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled..
- Recalling firm
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-09-23
- Terminated
- 2012-09-28
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
Reason for recall
The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled.
Data sourced from openFDA. This site is unofficial and independent of the FDA.