Recall Z-3042-2018— LeMaitre Vascular, Inc.
Class II · Terminated
Class II FDA medical device recall by LeMaitre Vascular, Inc., initiated 2018-06-19, terminated 2019-04-17. It names one FDA 510(k) clearance: K173323. Product: AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the forming of an anastomosis or closing of a vessel with possible intraluminal penetration.. Reason: The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided lists some indications which are not cleared by the FDA for devices distributed in the United States: 1) closure of arteriotomies and veinotomies, 2) attachment of synthetic vascular prostheses, and 3) approximation of dural tissue..
- Recalling firm
- LeMaitre Vascular, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-19
- Terminated
- 2019-04-17
- Firm location
- Burlington, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the forming of an anastomosis or closing of a vessel with possible intraluminal penetration.
Reason for recall
The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided lists some indications which are not cleared by the FDA for devices distributed in the United States: 1) closure of arteriotomies and veinotomies, 2) attachment of synthetic vascular prostheses, and 3) approximation of dural tissue.
Data sourced from openFDA. This site is unofficial and independent of the FDA.