Implantable Cardioverter Defibrillators Recalled for Rare Therapy Delivery Failure
Certain Medtronic implantable defibrillators may fail to deliver high voltage therapy in rare cases due to a manufacturing defect. The recall affects approximately 61,404 units distributed worldwide.
What this means for you
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: FDA Class I medical device with a rare potential for therapy delivery failure. Although the hazard is theoretical with no reported illnesses or injuries in the source text, the consequence of failure—inability to deliver potentially life-saving therapy to a cardiac patient—justifies a High severity rating.
Plain-English summary
Medtronic is recalling certain Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Model Number DDMB1D4, manufactured with a specific feedthrough component. The recall affects approximately 61,404 units distributed in the United States and worldwide.
The recalled devices have a rare potential to produce reduced or no energy output during high-voltage therapy, typically 0-12 joules. This means when a patient experiences a dangerous heart rhythm, the device may fail to deliver adequate therapy to correct the condition.
Patients with these devices should contact Medtronic or their healthcare provider to determine if their device is affected. Healthcare providers can identify affected devices by model and serial number. Treatment decisions may include device replacement or other interventions determined by the patient's healthcare team.
The recalled product
- Product
- ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- reduced-energy-output
- therapy-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 00643169720497
- Lot Serial Numbers: PFZ236436H
- PFZ242339H
- PFZ247708H
- PFZ247891H
- PFZ250783H
- PFZ252117H
- PFZ259560H
- PFZ265053H
- PFZ271895H
- PFZ248688H
- PFZ254957H
- PFZ260373H
- PFZ273832H
- PFZ244136H
- PFZ245315H
- PFZ264212H
- PFZ271087H
- PFZ273388H
- PFZ238454H
Distribution
Distributed nationwide across the United States.
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