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Amplatzer torqvue delivery system

Official notice

26 Mar 2025

MediumHealth Canada

An official Health Canada notice concerns Amplatzer torqvue delivery system. 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 Published 2025-03-26.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77187

Official notice

2025-03-26

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

77187

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Affected products

Product 1

Affected products - Amplatzer Torqvue Delivery System, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 9-TVLPC4F90/080

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Abbott Medical, Amplatzer Torqvue Delivery System.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

77187

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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