Heartstring III Proximal Seal System
Brand(s)
Last updated
Summary
Product
Heartstring III Proximal Seal System
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Heartstring III Proximal Seal System | More than 10 numbers, contact manufacturer. | HSK-3038 |
| Heartstring III Proximal Seal System | More than 10 numbers, contact manufacturer. | HSK-3043 |
Issue
Three primary failure modes have been identified.
- Failure of the heartstring seal to load.
- Failure of the heartstring seal to deploy into the aortotomy
- Failure of the deployed heartstring seal to provide adequate hemostasis
Recall start date: August 14, 2025
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Maquet Cardiovascular LLC
45 Barbour Pond Drive, Wayne, New Jersey, United States, 07470
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77998
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