Recall MonitorHealth Products
Heartstring III Proximal Seal System
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: Heartstring III Proximal Seal System
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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