Home › Device types › MAL
Graft, Vascular, Synthetic/Biologic Composite
FDA product code MAL · Class 2 · Cardiovascular
373
Registered devices
878
Adverse events
49
Recalls
6
510(k) clearances
Devices with this code
AlboGraft Polyester Vascular Graft — Lemaitre Vascular, Inc.AlboGraft Polyester Vascular Graft — Lemaitre Vascular, Inc.SealPTFE™ — VASCUTEK LTDHemashield — INTERVASCULAR SASHemashield — INTERVASCULAR SASHemashield — INTERVASCULAR SASHemashield — INTERVASCULAR SASAlboGraft Polyester Vascular Graft — Lemaitre Vascular, Inc.SealPTFE™ — VASCUTEK LTDHemashield — INTERVASCULAR SASHemashield — INTERVASCULAR SASGelseal™ — VASCUTEK LTDGelseal™ — VASCUTEK LTDHemashield — INTERVASCULAR SASAlboGraft Polyester Vascular Graft — Lemaitre Vascular, Inc.Gelseal™ — VASCUTEK LTDHemashield — INTERVASCULAR SASHemashield — INTERVASCULAR SASGelseal™ — VASCUTEK LTDAlboGraft Polyester Vascular Graft — Lemaitre Vascular, Inc.Gelseal™ — VASCUTEK LTDAlboGraft Polyester Vascular Graft — Lemaitre Vascular, Inc.AlboGraft Polyester Vascular Graft — Lemaitre Vascular, Inc.Gelseal™ — VASCUTEK LTD
Recent 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 pa |
| 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 M0020 |
| 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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