Medtronic Recalls MRI-Conditional Cardiac Resynchronization Therapy Devices
Medtronic is recalling specific MRI-conditional CRT-D devices due to an unexpected transient mode switch behavior detected during systems testing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (implanted cardiac device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Medtronic Inc. is recalling the Amplia MRI Quad CRT-0 SureScan, Claria MRI Quad CRT-D SureScan, and Compia MRI Quad CRT-D SureScan devices. The recall involves 25,025 units, with 16,369 distributed in the United States and 8,656 distributed outside the U.S. The devices were distributed nationwide in the U.S., including DC and Puerto Rico, as well as to numerous countries worldwide.
The recall was initiated because Medtronic detected an unexpected transient mode switch behavior during systems testing. This issue affects the specific MRI-conditional cardiac resynchronization therapy devices listed in the recall notice.
Patients with these implanted devices should contact their healthcare provider for guidance on monitoring and potential corrective actions. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure
- Hazard
Distribution
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