Heartstring III Proximal Seal System Recall Due to Device Failure Risks
Maquet Cardiovascular is recalling the Heartstring III Proximal Seal System (4.3 MM) due to three failure modes: failure to load, deploy, or provide adequate hemostasis. Healthcare providers should contact the manufacturer for guidance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with identified failure modes affecting critical surgical function (hemostasis). While no patient injuries have been reported, the device represents a documented risk of harm if the seal fails to function during vascular surgery.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Heartstring III Proximal Seal System, 4.3 MM, an intravascular anastomosis occluder used in vascular surgery. Approximately 12,471 units have been distributed worldwide, including 6,565 in the United States and 5,906 outside the US.
Three failure modes have been identified in this device: failure of the Heartstring Seal to load, failure of the seal to deploy into the aortotomy, and failure of the deployed seal to provide adequate hemostasis. These failures could prevent proper vascular occlusion during surgery, potentially resulting in uncontrolled bleeding.
The affected devices are Model No. HSK-3043 with specific serial numbers documented by the FDA. Distribution includes healthcare facilities nationwide and in 34 countries including Canada, Australia, Western Europe, Asia, and the Middle East.
Healthcare facilities and physicians who have these devices should immediately contact Maquet Cardiovascular for instructions. Patients who have received this device should consult with their surgical team.
The recalled product
- Product
- Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
- Manufacturer
- Maquet Cardiovascular, LLC
- Hazard
- device-malfunction
- hemostasis-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model No. HSK-3043
- UDI: 00607567700321
- Serial No. 3000379223
- 3000382433
- 3000385929
- 3000391405
- 3000399719
- 3000404541
- 3000406469
- 3000408189
- 3000411816
- 3000414253
- 3000414613
- 3000415212
- 3000419765
- 3000421682
- 3000422957
- 3000427645
- 3000428019
- 3000429074
Distribution
Distributed nationwide across the United States.
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