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FDAOctober 21, 2015device

LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

lemaitre vascularlemaitre

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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