Recall Z-0729-2022 ยท MAL Graft, Vascular, Synthetic/Biologic Composite
Maquet Cardiovascular, LLC
HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. Product Code/REF Number: M002020952070
| Date | Jan 14, 2022 |
| Status | Terminated |
| Reason | 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 (HEMASHIELD GOLD Knitted Microvel Double Velour Straight Vascular Graft, D: 7 mm L: 60 cm). Mislabeled product could cause a disruption of the vascular anastomosis in the long term, creating a pseudo-aneurysm |
| Root cause | Packaging process control |
| Action | Getinge issued Urgent Medical Device Letter onJanuary 14, 2022, (via FedEx overnight) with adult signature required. Letter states reason for recall, health risk and action to take: Actions to be taken: " If you have already implanted the above-mentioned device, kindly notify us as soon as possible by contacting your Getinge representative or Customer Service (at 1-888-943-8872, options 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST. You will be contacted shortly by our Medical Affairs Officer in order to discuss the appropriate follow up. " Please examine your inv |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the state of MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K954848 | HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT Meadox Medicals, Div. Boston Scientific Corp., Feb 1, 1996 |