Overview of recall records associated with ev3 Inc., including dates, categories and classifications where available.
Classification mix: Class I: 4, Class II: 2.
There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.
The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
Labeling discrepancy for the Rated Burst Pressure (RBP) value.
This page summarizes recall records in which the official source identifies ev3 Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
