Maquet Cardiovascular, LLC: Medical Device Recall in 2021 - (Recall #: Z-0403-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890

Product Classification:

Class II

Date Initiated: December 1, 2021

Date Posted: December 29, 2021

Recall Number: Z-0403-2022

Event ID: 89119

Reason for Recall:

There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely packaged inside of the carton instead of a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1260004700; 18 mm x 9 mm; REF Number M002020851890 or a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1259882880; 18 mm x 9 mm; Ref Number M002020851890.

Status: Terminated

Product Quantity: 2

Code Information:

Lot number: 20C04; Serial Numbers: 1260004700 and 1259882880; UDI Code: (01)00384401017752(11)200304(17)250228(21)1260004700GS(10)20C04 (01)00384401017752(11)200304(17)250228(21)1259882880GS(10)20C04

Distribution Pattern:

US Nationwide distribution in the states of IL and NC.

Voluntary or Mandated:

Voluntary: Firm initiated