Z-1769-2013Class I

AlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 AlboGraft Vascular Grafts are made of...

Name: Z-1769-2013 AlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 AlboGraft Vascular Grafts are made of...
Creator: LeMaitre Vascular, Inc.
Published: 2013-06-17
License: https://open.fda.gov/license/

LeMaitre Vascular Inc. / initiated 2013-06-17 / Terminated / root cause: manufacturing process

FDA source

LeMaitre Vascular, Inc. began a recall of AlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections... on 2013-06-17. FDA classified it as Class I and gives the reason as "Blood blushing/leaking from the surface of the graft after implantation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1769-2013
Classification: Class I
Status: Terminated
Initiated: 2013-06-17
Posted: 2013-07-22
Terminated: 2016-08-15
Recalling firm: LeMaitre Vascular Inc.
Product: AlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Product code: MAL Graft, Vascular, Synthetic/Biologic Composite
Reason for recall: Blood blushing/leaking from the surface of the graft after implantation
Root cause tag: manufacturing process
FDA root cause: Process control
Action: LeMaitre Vascular, Inc.sent an Urgent Field Safety Notice daed June 19, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify and return the affected device to MeMaitre Vascular which they will replace with a new unit. Customers with questions were instructed to call 781-221-2266, ext. 183. For questions regarding this recall call 781-425-1670, ext 108.
Quantity in commerce: 2 units
Distribution: Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.
Product codes and lots: Lot number/Expiration Date 56890A 2015-04

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1769-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1754-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-22
Z-1755-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-22
Z-1756-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-22
Z-1757-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-22
Z-1758-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-22
Z-1759-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-22
Z-1760-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-22
Z-1761-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-22
Z-1762-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-22
Z-1763-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-22
Z-1764-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-22
Z-1765-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-22
Z-1766-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-22
Z-1767-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-22
Z-1768-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-22
Z-1769-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-22
Z-1770-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-22

Product code MAL

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)