FDA-Device2015-12-16Class II
LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.
LeMaitre Vascular, Inc.
Hazard
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Sold states
Worldwide Distribution. US nationwide including PUERTO RICO, and Australia, AUSTRIA, BELGIUM, COLOMBIA, COSTA RICA, Czech Republic, DENMARK, EGYPT, FRANCE, GERMANY, ICELAND, Italy, JAPAN, JORDAN, Latvia, LUXEMBOURG, MOROCCO, NETHERLANDS, Norway, Oman, PERU, PORTUGAL, Poland, Slovenia, Spain, Switzerland, Sweden, THAILAND, United Kingdom, United Arab Emirates, and VIETNAM.
Affected count
4315 total
Manufactured in
63 2nd Ave, N/A, Burlington, MA, United States
Products
LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0384-2016Don't want to check this manually?
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