CLASS I Device recall · Reported 31 Jul 2013 · FDA Enforcement Report

AlboGraft Knitted with Collagen, Straight recalled by LeMaitre Vascular

LeMaitre Vascular is recalling AlboGraft Knitted with Collagen, Straight, distributed in Georgia, Pennsylvania. The recall was initiated on 17 Jun 2013 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot number/Expiration Date 56890A 2015-04

Quantity recalled3 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1761-2013
FDA event ID: 65553
Recalling firm: LeMaitre Vascular, Burlington, MA
Classification: Class I
Status: Terminated
Recall initiated: 17 Jun 2013
FDA classified: 22 Jul 2013
Reported: 31 Jul 2013
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

17 Jun 2013	Recall initiated by company
22 Jul 2013	Classified by FDA	+35 days
31 Jul 2013	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Blood blushing/leaking from the surface of the graft after implantation

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

AlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Where it was distributed

Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.

Georgia Pennsylvania

Questions about this recall

Is AlboGraft Knitted with Collagen, Straight recalled?

Yes. LeMaitre Vascular recalled AlboGraft Knitted with Collagen, Straight on 17 Jun 2013. The recall is Class I and its status is Terminated. Recall number Z-1761-2013.

Why was it recalled?

Blood blushing/leaking from the surface of the graft after implantation

Which lots are affected?

Lot number/Expiration Date 56890A 2015-04

Where was it sold?

Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from LeMaitre Vascular

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Reported	Class	Recall	Company	Reason	Where
25 Mar 2026Device	CLASS II	Artegraft Vascular Graft recalled by LeMaitre Vascular	LeMaitre Vascular	Packaging Defects	Nationwide
29 Oct 2025Device	CLASS II	Artegraft¿ Collagen Vascular Graft recalled by LeMaitre Vascular	LeMaitre Vascular	Packaging Defects	AR
15 Oct 2025Device	CLASS II	Artegraft Collagen Vascular Graft recalled by LeMaitre Vascular	LeMaitre Vascular	Labeling Errors	Nationwide
8 Oct 2025Device	CLASS II	Artegraft Collagen Vascular Grafts recalled by LeMaitre Vascular	LeMaitre Vascular	Other	Nationwide
21 May 2025Device	CLASS II	Pruitt Irrigation Occlusion Catheter recalled by LeMaitre Vascular	LeMaitre Vascular	Sterility	Nationwide

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