Maquet Cardiovascular, LLC: Medical Device Recall in 2022 - (Recall #: Z-0729-2022)

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:

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

Product Classification:

Class II

Date Initiated: January 14, 2022

Date Posted: March 16, 2022

Recall Number: Z-0729-2022

Event ID: 89573

Reason for Recall:

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

Status: Terminated

Product Quantity: 1 unit

Code Information:

Lot Number: 21B10 S/N: 1318567653 UDI: (01)00384401017608(11)210210(17)260131(21)1318567653GS(10)21B10

Distribution Pattern:

US Nationwide distribution in the state of MO.

Voluntary or Mandated:

Voluntary: Firm initiated