Home › Lemaitre Vascular, Inc. › AlboGraft Polyester Vascular Graft
AlboGraft Polyester Vascular Graft
Lemaitre Vascular, Inc. · Model ATC1207 · UDI-DI 00840663104147
MAL
Prescription
2
510(k) clearances
878
Adverse events (43 deaths)
49
Recalls
7
Facilities
Description
AlboGraft Polyester Vascular Graft 12cmx7mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-01-14 | Maquet Cardiovascular, LLC | Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40 cm) does not correspond to the (inner) sterile packaging labelling (H |
| 2021-12-01 | Maquet Cardiovascular, LLC | There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely |
| 2020-04-07 | Maquet Cardiovascular, LLC | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 | Maquet Cardiovascular, LLC | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 | Maquet Cardiovascular, LLC | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 | Maquet Cardiovascular, LLC | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 | Maquet Cardiovascular, LLC | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 | Maquet Cardiovascular, LLC | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 | Maquet Cardiovascular, LLC | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 | Maquet Cardiovascular, LLC | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.