FDA Device recall Z-1567-2020

LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88

• FDA Device
• Class I
• ongoing
• Published 2020-04-08

On 2020-04-08 the FDA classified a Class I recall of LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88 by Lemaitre Vascular, citing there has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.

Read the official FDA Device notice

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1567-2020%22

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