Health product recall

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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