FDA (Devices) recall action 65553

LeMaitre Vascular, Inc. recalled 17 products on 2013-07-31

The FDA (Devices) publishes a recall like this one as 17 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 17 pages.

Products: 17
Announced: 2013-07-31
Critical: 5
Units: 39

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–17 of 17

SevereFDA (Devices)··2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Post-Implantation Blood Leakage
LeMaitre Vascular is recalling AlboGraft Woven with Collagen vascular grafts due to blood blushing or leaking from the graft surface after implantation.
Product
AlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Distribution
1 state
SevereFDA (Devices)··2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Surface Bleeding
LeMaitre Vascular is recalling AlboGraft Woven with Collagen grafts due to blood blushing or leaking from the surface after implantation.
Product
AlboGraft Woven with Collagen, Straight 30x16 Catalog Number: ATC3016 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Distribution
1 state
SevereFDA (Devices)··2013-07-31
LeMaitre Recalls AlboGraft Vascular Grafts Due to Blood Leakage
LeMaitre Vascular is recalling specific AlboGraft vascular grafts because blood may blush or leak from the surface after implantation.
Product
AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Distribution
1 state
SevereFDA (Devices)··2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Surface Bleeding
LeMaitre Vascular is recalling specific AlboGraft Vascular Grafts due to blood blushing or leaking from the graft surface after implantation.
Product
AlboGraft Knitted with Collagen, Straight 15x06 Catalog Number: AMC1506 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Distribution
1 state
SevereFDA (Devices)··2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Post-Implantation Bleeding
LeMaitre Vascular is recalling AlboGraft Knitted with Collagen grafts due to blood blushing or leaking from the graft surface after implantation.
Product
AlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Distribution
1 state
SevereFDA (Devices)··2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Post-Implantation Bleeding
LeMaitre Vascular is recalling AlboGraft Knitted with Collagen vascular grafts due to blood blushing or leaking from the graft surface after implantation.
Product
AlboGraft Knitted with Collagen, Straight 40x07 Catalog Number: AMC4007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Distribution
1 state
SevereFDA (Devices)··2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Surface Bleeding
LeMaitre Vascular is recalling two units of AlboGraft Knitted with Collagen vascular grafts due to blood blushing or leaking from the graft surface after implantation.
Product
AlboGraft Knitted with Collagen, Straight 60x07 Catalog Number: AMC6007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Distribution
1 state
CriticalFDA (Devices)··2013-07-31
LeMaitre Recalls AlboGraft Vascular Grafts Due to Blood Leakage
LeMaitre Vascular is recalling 3 units of AlboGraft Knitted with Collagen, Bifurcate 18x09 due to blood blushing or leaking from the graft surface after implantation.
Product
AlboGraft Knitted with Collagen, Bifurcate 18x09 Catalog Number: AMC1809 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Distribution
1 state
SevereFDA (Devices)··2013-07-31
LeMaitre Recalls AlboGraft Vascular Grafts Due to Blood Leaking
LeMaitre Vascular is recalling two units of AlboGraft Woven with Collagen vascular grafts because blood may leak from the graft surface after implantation.
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.
Category
Distribution
1 state
SevereFDA (Devices)··2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Surface Leaking
LeMaitre Vascular, Inc. is recalling specific AlboGraft vascular grafts because they may leak blood from the surface after being implanted in patients.
Product
AlboGraft Knitted with Collagen, Bifurcate 18x10 Catalog Number: AMC1810 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Distribution
1 state
SevereFDA (Devices)··2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Post-Implantation Bleeding
LeMaitre Vascular is recalling 3 units of AlboGraft Knitted with Collagen, Bifurcate 20x10 (Lot 56890A) due to blood blushing or leaking from the graft surface after implantation.
Product
AlboGraft Knitted with Collagen, Bifurcate 20x10Catalog Number: AMC2010 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Distribution
1 state
CriticalFDA (Devices)··2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Surface Leakage
LeMaitre Vascular is recalling 2 units of AlboGraft Woven with Collagen, Straight 15x26 (Lot 56890A) because blood blushing or leaking was observed from the graft surface after implantation.
Product
AlboGraft Woven with Collagen, Straight 15x26 Catalog Number: ATC1526 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Distribution
1 state
CriticalFDA (Devices)··2013-07-31
LeMaitre Recalls Albo Graft Vascular Implants Due to Surface Leaking
LeMaitre Vascular is recalling 7 units of Albo Graft Knitted with Collagen, Bifurcate 16x08 due to blood blushing or leaking from the graft surface after implantation.
Product
Albo Graft Knitted with Collagen, Bifurcate 16x08 Catalog Number: AMC1608 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Distribution
1 state
SevereFDA (Devices)··2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Surface Bleeding
LeMaitre Vascular is recalling 3 units of AlboGraft Knitted with Collagen vascular grafts due to blood blushing or leaking from the graft surface after implantation.
Product
AlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Distribution
1 state
CriticalFDA (Devices)··2013-07-31
LeMaitre Vascular Recalls AlboGraft Vascular Grafts Due to Surface Leaking
LeMaitre Vascular is recalling 3 units of AlboGraft Knitted with Collagen vascular grafts because they may leak blood from the surface after implantation.
Product
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.
Category
Distribution
1 state
CriticalFDA (Devices)··2013-07-31
LeMaitre Recalls AlboGraft Vascular Grafts Due to Surface Bleeding
LeMaitre Vascular is recalling 3 units of AlboGraft Woven with Collagen, Straight 30x26 (Lot 56890A) because blood blushing or leaking was observed from the graft surface after implantation.
Product
AlboGraft Woven with Collagen, Straight 30x26 Catalog Number: ATC3026 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Distribution
1 state
SevereFDA (Devices)··2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Post-Implantation Bleeding
LeMaitre Vascular is recalling AlboGraft Woven with Collagen grafts due to blood leaking from the graft surface after implantation.
Product
AlboGraft Woven with Collagen, Straight 30x18 Catalog Number: ATC3018 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Distribution
1 state