Maquet Cardiovascular, LLC: Medical Device Recall in 2022 - (Recall #: Z-1282-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: April 29, 2022

Date Posted: June 29, 2022

Recall Number: Z-1282-2022

Event ID: 90272

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

Status: Terminated

Product Quantity: 1 unit

Code Information:

UDI: (01)00384401000280(11)201112(17)251031(21)1303435656GS(10)20L12; Lot number: 20L12 Serial number: 1303435656

Distribution Pattern:

US Nationwide distribution in the state of SC.

Voluntary or Mandated:

Voluntary: Firm initiated