Recall Z-1282-2022— Maquet Cardiovascular, LLC
Class II · Terminated
Class II FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2022-04-29, terminated 2024-04-18. It names one FDA 510(k) clearance: K984294. Product: 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. 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.
- Recalling firm
- Maquet Cardiovascular, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-04-29
- Terminated
- 2024-04-18
- Firm location
- Wayne, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.