Maquet Cardiovascular, LLC: Medical Device Recall in 2023 - (Recall #: Z-0995-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Hemopro 2 with Vasoshield, Model VH-4001

Product Classification:

Class II

Date Initiated: December 22, 2022

Date Posted: January 25, 2023

Recall Number: Z-0995-2023

Event ID: 91363

Reason for Recall:

Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral embolic event.

Status: Ongoing

Product Quantity: 9817 devices

Code Information:

UDI-DI: 00607567700901; Serial Numbers: 25152107, 25152204, 25152293, 25152463, 25152771, 25153153, 25153273, 25153366, 25153585, 25153847, 25153960, 25154066, 25154880, 25155262, 25155326, 25155785, 25156245, 25156642, 25157016, 25157085, 25157244, 25157700, 25157898, 25158066, 25158152, 25158374, 25158822, 25158965, 25159100, 25159335, 25159572, 25159695, 25159791, 25160255, 25160398, 25160498, 25160712, 25160961, 25161193, 25161423, 25161672, 25162202, 25162407, 25162505, 25163168, 25163281, 25163367, 3000236928, 3000251969

Distribution Pattern:

US Nationwide. Japan, Germany.

Voluntary or Mandated:

Voluntary: Firm initiated