Recall Z-2402-2021— Micro Therapeutics Inc,

Name: FDA recall Z-2402-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-13

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: Pipeline Flex Embolization Device. 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

Pipeline Flex Embolization Device

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.