Z-1282-2022 Class II Terminated
FDA device recall Z-1282-2022 was initiated by Maquet Cardiovascular, LLC on Apr 29, 2022 and is designated Class II. 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 The recall status is terminated (terminated Apr 18, 2024). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 29, 2022
- Initiation Date
- Apr 29, 2022
- Termination Date
- Apr 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
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
Distribution Pattern
US Nationwide distribution in the state of SC.
Code Information
UDI: (01)00384401000280(11)201112(17)251031(21)1303435656GS(10)20L12; Lot number: 20L12 Serial number: 1303435656
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1282-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026