AlboGraft Polyester Vascular Graft AMC1207Recalls & reported problems
Lemaitre Vascular, Inc. · AlboGraft Polyester Vascular Graft 12cmx7mm · Class 2 · Implant
All models of AlboGraft Polyester Vascular Graft (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840663103423), received between May 17, 2018 and Oct 10, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak2
- Inflation Problem1
Patient problems
- Aneurysm1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 10, 2018Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem
DURING CAROTID ENDARTERECTOMY, THE INTERNAL CAROTID BALLOON FAILED TO INFLATE PROPERLY. AS A RESULT, BLOOD WAS LEAKING OUT FROM THE PATIENT'S VESSEL DURING ANASTOMOSIS SINCE THE BALLOON WAS UNABLE TO COMPLETELY OCCLUDE THE ARTERY. THIS IS A FOLLOW-UP REPORT OF MANUFACTURER'S INCIDENT REPORT 1220948-2018-00059 THAT WAS INITIALLY PROVIDED ON (B)(6) 2018.
Patient problems: Aneurysm
MAUDE report 7952761 ↗MalfunctionMay 17, 2018Fluid/Blood Leak; Fluid/Blood Leak
BLOOD WAS OOZING FROM LEFT LIMB OF THE GRAFT NEAR THE SITE OF BIFURCATION ONCE THE SUPPORTING CLAMP WAS REMOVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7523406 ↗
Other Graft, Vascular, Synthetic/Biologic Composite devices
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- Hemashield M002020851890Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite1 recall2 reports
- Hemashield M002020952070Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite1 recall0 reports
- Hemashield M00202175928P0Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite10 reports
- Hemashield M00202175210P0Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite8 reports
- Hemashield M00202175208P0Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite8 reports
- AlboGraft Polyester Vascular Graft AMC1407Lemaitre Vascular, Inc. · Graft, Vascular, Synthetic/Biologic Composite6 reports
- Hemashield M00202175430P0Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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