LeMaitre Vascular, Inc. recalls LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Ov

Recalled April 8, 2020 · FDA recall Z-1567-2020 · LeMaitre Vascular

Hazard

There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation. · FDA Class I

Units

43315

Sold at

Worldwide distribution: US (Nationwide distribution) and foreign countries of: Australia, Austria, Belgium, Bulgaria, Colombia, Costa Rica, Czech Republic, Dominican Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Georgia, Hungary, Ireland, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam.

Description

There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.

Product

LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration.

Manufacturer(s)

LeMaitre Vascular, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →