Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.
Device
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.
There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.
Recall record
Recall number
Z-1567-2020
Classification
Class I
Status
Ongoing
Voluntary or mandated
Voluntary: Firm initiated
Firm notification
Letter
Distribution
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.
Recall initiated
2020-03-23
Classified by FDA Center
2020-04-01
FDA published
2020-04-08
Recalling firm
LeMaitre Vascular, Inc.
Firm location
Burlington, MA
Operational response
A Class I device recall indicates a strong likelihood of serious adverse
health consequence or death from continued use. Identify affected units
by serial number, lot, or GTIN against your inventory and against
implanted-device patient registry. Pull affected inventory from active
use immediately. For implanted devices, follow the recalling firm’s
patient-notification protocol; in most cases this requires informing
affected patients and their treating physicians directly.