Public recall detail

Amplatzer Torqvue Delivery System

2025-03-26

medium
Recall Safety notice
Quick summary

Quick summary: Amplatzer Torqvue Delivery System. Date: 2025-03-26.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Amplatzer Torqvue Delivery System. Date: 2025-03-26.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandABBOTT MEDICAL
ProductAmplatzer Torqvue Delivery System
IssueMedical devices - Performance
Recall classType II
IdentificationRA-77187

Affected products

ProductAmplatzer Torqvue Delivery System
LotMore than 10 numbers, contact manufacturer.
Model9-TVLPC4F90/080
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAmplatzer Torqvue Delivery System
ProductAmplatzer Torqvue Low Profile Delivery System
LotMore than 10 numbers, contact manufacturer.
Model9-TVLP4F90/060 9-TVLP4F90/080
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAmplatzer Torqvue Low Profile Delivery System

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesAbbott Medical 5050 Nathan Lane North, Plymouth, Minnesota, United States, 55442
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-77187
Background{}
CompaniesAbbott Medical 5050 Nathan Lane North, Plymouth, Minnesota, United States, 55442
AudiencesHealthcare
Source updated2025-03-26

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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