Heartstring III Proximal Seal System Recalls Due to Deployment and Hemostasis Failures
The FDA is recalling the Heartstring III Proximal Seal System due to failures in loading, deploying, or providing hemostasis during aortotomy closure. Affected devices may not properly seal, creating a risk of bleeding during cardiac surgery.
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: This is an FDA Class II medical device recall for an intravascular cardiac surgical device with identified failure modes that could result in inadequate hemostasis (bleeding control) during aortotomy closure. While no reported illnesses or injuries are documented in the source, the potential for serious intraoperative or postoperative bleeding complications warrants a High severity rating.
Plain-English summary
The Heartstring III Proximal Seal System is an intravascular anastomosis occluder device manufactured by Maquet Cardiovascular, LLC. It is used during cardiac surgery to seal and close aortotomies (openings in the aorta). The device was distributed worldwide, including throughout the United States and 34 other countries.
The FDA has identified three failure modes in affected units: the Heartstring Seal may fail to load into the delivery system, may fail to deploy into the aortotomy, or once deployed, may fail to provide adequate hemostasis (bleeding control). These failures could result in incomplete sealing of the aortotomy, creating a risk of blood loss during or after surgery.
A total of 126 units have been recalled (91 distributed in the United States, 35 internationally), identified by specific serial numbers. Healthcare providers using or who may have used this device should contact Maquet Cardiovascular, LLC regarding replacement options or further guidance. Patients who have undergone procedures using this device should consult with their healthcare provider if they experience unusual symptoms or complications.
The recalled product
- Product
- Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
- Manufacturer
- Maquet Cardiovascular, LLC
- Category
- Medical Device — Cardiovascular
- 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 (10)
- Model No. HS-3045
- UDI: 00607567700307
- Serial No. 3000365549
- 3000428264
- 3000447331
- 3000460255
- 3000365549
- 3000390361
- 3000420107
- 3000475915.
Distribution
Distributed nationwide across the United States.
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