Maquet Cardiovascular recalled the Heartstring III Proximal Seal System on August 15, 2025, due to three identified failure modes. These failures include issues with the seal's loading, deployment, and hemostasis. The recall affects 168 units distributed worldwide.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Maquet Cardiovascular, LLC or your healthcare provider for instructions. Notification method: Letter
The recalled Heartstring III Proximal Seal System includes model HS-3045 and UDI 00607567700307. Other serial numbers affected are 3000365549, 3000428264, 3000447331, 3000460255, 3000390361, 3000420107, and 3000475915. The device was distributed in various countries, including the US, Canada, and several European nations.
The recall addresses high-risk failure modes that can lead to inadequate hemostasis during medical procedures. Such failures can pose significant risks to patients undergoing vascular surgeries.
No specific incidents or injuries have been reported related to this recall. The manufacturer emphasizes immediate cessation of use.
Patients and healthcare providers must stop using the device immediately. Follow the recall instructions provided by the manufacturer. Contact Maquet Cardiovascular or your healthcare provider for further guidance.
For more details, contact Maquet Cardiovascular at their official website or through the recall notification letter.
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Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.