Maquet Cardiovascular, LLC

16 FDA enforcement actions

16 Total Recalls

3 Class I

13 Class II

0 Class III

Firm Details

Product Types: device
States: NJ

All Recalls

Class II: Risk 08/15/2025 device

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 device

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 device

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 device

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 device

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 device

Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.
Class I: Dangerous 12/09/2024 device

Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
Class I: Dangerous 12/09/2024 device

Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
Class II: Risk 10/16/2024 device

Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.
Class II: Risk 10/16/2024 device

Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.
Class II: Risk 10/16/2024 device

Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.
Class I: Dangerous 09/20/2024 device

There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.
Class II: Risk 05/31/2024 device

There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between C-Ring and Harvesting Tool was closer than normal. No adverse events have been reported to date in direct association with this issue.
Class II: Risk 05/31/2024 device

There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between C-Ring and Harvesting Tool was closer than normal. No adverse events have been reported to date in direct association with this issue.
Class II: Risk 05/17/2024 device

Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.
Class II: Risk 05/17/2024 device

Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.