Recall Z-2403-2021— Micro Therapeutics Inc,
Class I · Ongoing
Class I FDA medical device recall by Micro Therapeutics Inc,, initiated 2021-07-13. FDA's recall record names no specific 510(k) clearance for this event. Product: EV3 Pipeline Flex Embolization Device with Flex Shield Technology. Reason: Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube..
- Recalling firm
- Micro Therapeutics Inc,
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2021-07-13
- Firm location
- Irvine, CA, United States
Product description
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
Reason for recall
Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.
Data sourced from openFDA. This site is unofficial and independent of the FDA.