Heartstring III Proximal Seal System Recalled for Loading and Deployment Failures
Maquet Cardiovascular is recalling 28,331 units of the Heartstring III Proximal Seal System for three failure modes: inability to load, failure to deploy, and inadequate hemostasis. The device is used during aortotomy procedures.
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 recall of a critical surgical device with three identified failure modes affecting loading, deployment, and hemostasis function. The High classification reflects the risk-of-harm nature of the product and its vital function in vascular procedures, consistent with the rubric criterion for risk-of-harm products where injury has not been reported in the source material.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Heartstring III Proximal Seal System, Model HSK-3038, an intravascular anastomosis occluder used during aortotomy procedures. The recall affects approximately 28,331 units: 16,615 distributed in the United States and 11,716 distributed internationally.
Three failure modes have been identified in the device. The Heartstring Seal may fail to load, fail to deploy into the aortotomy, or fail to provide adequate hemostasis once deployed. These failures could affect the device's function during surgical procedures.
The affected device is identified by Model Number HSK-3038 and Universal Device Identifier (UDI) 00607567700314. Specific serial numbers are provided in the recall notification for precise identification of affected units.
The recalled product
- Product
- Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
- Manufacturer
- Maquet Cardiovascular, LLC
- Hazard
- loading-failure
- deployment-failure
- 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-3038
- UDI: 00607567700314¿
- Serial No. 3000377764
- 3000378278
- 3000379222
- 3000379987
- 3000383569
- 3000388598
- 3000390377
- 3000394076
- 3000396875
- 3000398149
- 3000400694
- 3000402932
- 3000403566
- 3000404026
- 3000404996
- 3000405699
- 3000407693
- 3000409172
Distribution
Distributed nationwide across the United States.
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