Medtronic MRI-Conditional Cardiac Devices Recalled for Software Feature Error
Medtronic is recalling 21,111 MRI-conditional cardiac resynchronization therapy devices because the AdaptivCRT feature may appear enabled when it is not active.
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 the hazard involves a potential failure of a therapeutic feature in a life-sustaining medical device, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Inc. is recalling 21,111 units of the Amplia MRI CRT -D SureScan, Amplia MRI Quad CRT -D SureScan, Claria MRI CRT -D SureScan, and Claria MRI Quad CRT -D SureScan implantable medical devices. These devices are designed to automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia.
The recall was initiated after internal testing conducted during next-generation product development revealed that the AdaptivCRT (aCRT) feature of these devices may appear to be enabled when it is not actually active. This software error could lead to a lack of expected therapeutic benefit for patients relying on the aCRT feature.
The affected devices were distributed in all US states, including DC and Puerto Rico, as well as in numerous countries outside the US, including Australia, Finland, Japan, and the United Kingdom. Patients with these devices should contact their healthcare provider to discuss the recall and determine if any action is required.
The recalled product
- Product
- Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", Claria MRI" Quad CRT -D SureScan. implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular…
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure
Distribution
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