Recall Z-1282-2022 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Maquet Cardiovascular, LLC
INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner surface. The device is available in straight tubes and bifurcated configurations, as well as hemabridge, aortic arch, thoracic aortic graft, and cardioroot configurations designed for use on the thoracic aorta
| Date | Apr 29, 2022 |
| Status | Terminated |
| Reason | Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm, contained an Intergard Woven Straight graft of D: 32 mm and L: 30 cm |
| Root cause | Packaging process control |
| Action | Intervascular SAS / Getinge issued Urgent Medical Device Removal letter via mail on April 29, 2022. Letter stated reason for recall, health risk and action to take: Please examine your inventory immediately to determine if you have the INTERGARD Woven Straight graft, Ref Number IGW0032-30, Lot 20L12, SN 1303435656. Please make sure that the affected product is segregated in a secure storage place to prevent any use of the product. Should you have the unused affected product, you are eligible for credit upon receipt of the Response Form (see page 4). Please contact Getinge Customer Service at |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the state of SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984294 | MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES Intervascular, Inc., Feb 22, 1999 |