There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
Class IIReported ongoing
Distribution: Worldwide distribution - US (& PR) Nationwide and the countries of Chile, Cyprus, Estonia, Germany, Italy, Japan, Jordan, Puerto Rico, Spain, United States, Uzbekistan, and Yemen.
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.
Class IReported terminated
Distribution: US Nationwide distribution in the states of AZ, CA, FL, IA, IL, KS, LA, MI, MS, NC, NJ, NY, OR, SC, SD, TN, TX, and VA.
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.
Class IReported terminated
Distribution: US Nationwide distribution in the states of AZ, CA, FL, IA, IL, KS, LA, MI, MS, NC, NJ, NY, OR, SC, SD, TN, TX, and VA.
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
Class IReported terminated
Distribution: Worldwide Distribution: US (nationwide), including PR; and Foreign distribution to countries of: Argentina, Australia, Austria, Belgium, Brazil, Chile, Colombia, Costa Rica, Cro...
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
Class IReported terminated
Distribution: Worldwide Distribution: US (nationwide), including PR; and Foreign distribution to countries of: Argentina, Australia, Austria, Belgium, Brazil, Chile, Colombia, Costa Rica, Cro...
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.
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
These examples come from this result page and are not a ranking of every recall reason.
Checking ev3 Inc.
Is there a recall on ev3 inc. right now?
This archive contains 5 records, including 1 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
How do I check my package or product?
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
Does a matching name mean every item is included?
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
What if the search finds no matching record?
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Where can I find older records?
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.