Amplatzer Torqvue Delivery System
Brand(s)
Last updated
Summary
Product
Amplatzer Torqvue Delivery 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 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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Abbott Medical
5050 Nathan Lane North, Plymouth, Minnesota, United States, 55442
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77187
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