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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