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Tacticath contact force ablation catheter, sensor enabled

Official notice

4 Jul 2022

MediumHealth Canada

An official Health Canada notice concerns Tacticath contact force ablation catheter, sensor enabled. Abbott is voluntarily recalling affected lots of the Tacticath Contact Force Ablation Catheter, Sensor Enabled (models A-TCSE-DF and A-TCSE-DD). In certain instances, the Tacticath Contact Force Ablation Catheter, Sensor Enabled generates an error when initially connected to the Tactisys that states the "contact force catheter is intended for single use only" and disables contact force sensing for affected catheters. Recall start date: March 24, 2022 Published 2022-07-04.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64328

Official notice

2022-07-04

The hazard

Abbott is voluntarily recalling affected lots of the Tacticath Contact Force Ablation Catheter, Sensor Enabled (models A-TCSE-DF and A-TCSE-DD). In certain instances, the Tacticath Contact Force Ablation Catheter, Sensor Enabled generates an error when initially connected to the Tactisys that states the "contact force catheter is intended for single use only" and disables contact force sensing for affected catheters. Recall start date: March 24, 2022

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

64328

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Affected products

Product 1

Affected products - Tacticath Contact Force Ablation Catheter, Sensor Enabled, Lot or Serial number - 8197913 8196343 8173365 8177442 8196367, Model or catalogue number - A-TCSE-DD A-TCSE-DF

Risk / hazard

Abbott is voluntarily recalling affected lots of the Tacticath Contact Force Ablation Catheter, Sensor Enabled (models A-TCSE-DF and A-TCSE-DD). In certain instances, the Tacticath Contact Force Ablation Catheter, Sensor Enabled generates an error when initially connected to the Tactisys that states the "contact force catheter is intended for single use only" and disables contact force sensing for affected catheters. Recall start date: March 24, 2022

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

Brand: Abbott Medical, Tacticath Contact Force Ablation Catheter Sensor Enabled.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64328

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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