Z-3042-2018Class II

AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue...

Name: Z-3042-2018 AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue...
Creator: LeMaitre Vascular, Inc.
Published: 2018-06-19
License: https://open.fda.gov/license/

LeMaitre Vascular Inc. / initiated 2018-06-19 / Terminated / root cause: labeling and UDI

FDA source

LeMaitre Vascular, Inc. began a recall of 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... on 2018-06-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3042-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-19
Posted: 2018-09-14
Terminated: 2019-04-17
Recalling firm: LeMaitre Vascular Inc.
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.
Product code: HBT Applier, Hemostatic Clip
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On June 19, 2018, the firm sent Urgent Medical Device Recall letters to affected consignees. The letters informed customers of the product labeling issue. Customers were asked to complete the customer reply form and return it to the firm, and to forward the recall to any other facilities where product had been distributed. After the customer service department receives the completed form, they will contact the customer to arrange for a return of the recalled product at no charge to the customers. Customer service will also arrange for customers to receive replacement product. If you have any questions concerning this recall, please contact Ms. Rose Lerer, Senior Quality Engineer, 781-425-1671 or [email protected].
Distribution: Distributed to accounts in FL, NV, OK, SC, and TX.
Product codes and lots: AGC2134

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3042-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3042-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-13

Product code HBT

K173323Class IIAnastoClip GC Closure SystemLeMaitre Vascular, Inc. / cleared 2018-03-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)