Recall Z-1567-2020— LeMaitre Vascular, Inc.

Name: FDA recall Z-1567-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-23

Class I · Ongoing

Class I FDA medical device recall by LeMaitre Vascular, Inc., initiated 2020-03-23. It names one FDA 510(k) clearance: K022145. 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.. Reason: There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation..

Recalling firm: LeMaitre Vascular, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2020-03-23
Firm location: Burlington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K022145 — OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302LeMaitre Vascular, Inc.·cleared 2003-01-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.