LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and thrombi.

Recall Insight

This FDA Devices action (record #Z-0390-2016) was formally reported on December 16, 2015, with the manufacturer initiating the action on October 21, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. LeMaitre Vascular, Inc. is listed as the recalling firm, operating out of Burlington, MA. Federal records indicate 4315 total units are affected.

The documented reason for this recall is: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. Distribution data in the federal record shows the product reached: 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, MO…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 11 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.