Maquet Cardiovascular, LLC: Device Recall

Recall Details

Recall Number

Z-2586-2025

Classification

Class II

Product Type

Device

Recalling Firm

Maquet Cardiovascular, LLC

Status

Ongoing

Date Initiated

08/15/2025

Location

Wayne, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

126 units (91 US, 35 OUS)

Reason for Recall

Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.

Product Description

Heartstring III Proximal Seal System. Intravascular anastomosis occluder.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom.

Other Recalls by Maquet Cardiovascular, LLC

• Class II: Risk 08/15/2025
  Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
• Class II: Risk 08/15/2025
  Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
• Class II: Risk 08/06/2025
  Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws not fully closed out of box, and heater wire lifted/flexed away from jaws.
• Class II: Risk 03/20/2025
  There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device. The ceramic C-Ring has a potential to break while in use. Maquet/Getinge determined that the issue was limited to the units of VH-4000 and VH-4001 manufactured with ceramic C-Ring, and the ceramic C-Ring was implemented in the Hemopro 2 devices from November 5, 2024, through February 14, 2025.
• Class II: Risk 03/10/2025
  Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.

View all recalls by Maquet Cardiovascular, LLC →