LeMaitre Vascular, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0389-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and thrombi.

Product Classification:

Class II

Date Initiated: October 21, 2015

Date Posted: December 16, 2015

Recall Number: Z-0389-2016

Event ID: 72534

Reason for Recall:

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Status: Terminated

Product Quantity: 4315 total

Code Information:

Lot Number: NSE1663

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated