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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with…"
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
- Affected units
- 61,404
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.
Part of a larger recall action
This product is one of 120 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 120 products in this recall →Related recalls
Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
See all →- SevereImplantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28
Same hazard · reduced energy output
See all →- SevereImplantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereImplantable defibrillators may deliver reduced or no energy during therapy
FDA (Devices) · 2023-06-28
- SevereImplantable cardioverter defibrillators may output reduced or no energy during therapy
FDA (Devices) · 2023-06-28
Similar recalls
- SevereCobalt Implantable Cardioverter Defibrillators recalled for reduced shock energy
FDA (Devices) · 2022-08-17
- SevereCobalt Implantable Cardioverter Defibrillators May Deliver Reduced Shock Energy
FDA (Devices) · 2022-08-17
- SevereMedtronic Recalls 78 Viva Quadripolar Implantable Cardioverter Defibrillators
FDA (Devices) · 2016-08-31
- SevereMedtronic Cobalt Implantable Defibrillators Recalled Due to Reduced Shock Energy Defect
FDA (Devices) · 2022-08-17
- SevereMedtronic EnTrust ICD Recall for Potential Loss of High Voltage Therapy
FDA (Devices) · 2018-07-18
- SevereMedtronic Visia AF ICDs Recalled for Potential Therapy Failure
FDA (Devices) · 2018-02-28