Recall Z-0308-2017— 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: Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04 FA-88810-30V06 FA-88810-40V04 FA-88810-40V06 FA-88810-50V04 FA-88810-50V06. 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
Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04 FA-88810-30V06 FA-88810-40V04 FA-88810-40V06 FA-88810-50V04 FA-88810-50V06
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.