Recall MonitorHealth Products
Amplatzer Torqvue Delivery System
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: Amplatzer Torqvue Delivery 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 catalog number |
|---|---|---|
| Amplatzer Torqvue Delivery System | More than 10 numbers, contact manufacturer. | 9-TVLPC4F90/080 |
| Amplatzer Torqvue Low Profile Delivery System | More than 10 numbers, contact manufacturer. | 9-TVLP4F90/060 9-TVLP4F90/080 |
Issue
Abbott is voluntarily recalling certain 4F Amplatzer™ Torqvue™ LP Delivery System (TVLP) and 4F Amplatzer™ Torqvue™ LP Catheter (TVLPC) devices, which were impacted by a manufacturing anomaly. Any impacted lots which have not yet been consumed should be returned to Abbott. All other lots are not affected and can continue to be used. To date, there have been no reports of patient harm associated with devices from the impacted lots. Recall Start Date: March 17, 2025