Trifecta Heart Valve
Brand(s)
Last updated
Summary
Product
Trifecta Heart Valve
Issue
Medical devices - Performance issue
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 |
---|---|---|
Trifecta Heart Valve | More than 10 numbers, contact manufacturer. | TF-23A TF-21A TF-25A TF-27A TF-19A TF-29A |
Trifecta Valve With Glide Technology | More than 10 numbers, contact manufacturer. | TFGT-23A TFGT-19A TFGT-27A TFGT-29A TFGT-25A TFGT-21A |
Issue
Abbott sent a customer communication on 2023-02-27 to raise awareness around the potential for early structural valve deterioration (SVD), a known risk associated with these devices, compared to other valves and to provide reminders and considerations with regards to this known risk. There are no new issues regarding safety, efficacy or usefulness of the device, and no changes to the approved labeling.
Recall start date: March 17, 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
St. Jude Medical
177 County Road B East, St. Paul, Minnesota, United States, 55117
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-73411
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