Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure Due to An unexpected transient mode switch behavior was detected...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Inc., Cardiac Rhythm and Heart Failure directly.
Affected Products
Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan
Quantity: 25,025 ( 16,369 US; 8,656 OUS)
Why Was This Recalled?
An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia' "', Claria'"', and Compia'"' Quad CRT-D MRI devices.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Inc., Cardiac Rhythm and Heart Failure
Medtronic Inc., Cardiac Rhythm and Heart Failure has 9 total recalls tracked by RecallDetector.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report