Maquet Cardiovascular recalled 32,867 units of the Heartstring III Proximal Seal System on August 15, 2025. Three failure modes can lead to inadequate hemostasis during procedures. Patients and healthcare providers must stop using this device immediately.
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 recall affects the Heartstring III Proximal Seal System, Model No. HSK-3038, with several serial numbers ranging from 3000377764 to 3000409172. These products were distributed worldwide, including the US and multiple other countries.
Three identified failure modes pose a high risk during medical procedures. These include failure to load the seal, failure to deploy into aortotomy, and failure to provide adequate hemostasis.
No specific incident counts are available. The hazards present a high risk of serious medical complications.
Stop using the device immediately. Contact Maquet Cardiovascular or your healthcare provider for further instructions and follow the recall instructions provided.
For more details, call Maquet Cardiovascular at 1-800-XXX-XXXX or visit their website. Additional information is available at the FDA's recall notification link.
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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.