Medtronic ICD Devices Potential Energy Output Failure During Therapy
Medtronic's implantable cardioverter defibrillators (ICDs) may produce reduced or no energy output during high voltage therapy due to a feedthrough defect. Patients with affected lot numbers should contact their healthcare provider.
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: FDA Class I recall, the agency's highest classification, indicating a serious health hazard. Although no illnesses or injuries have been reported, the potential for therapy delivery failure in an implanted life-saving cardiac device poses an inherent serious risk.
Plain-English summary
Medtronic Inc. is recalling certain Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices, Model DDPA2D4G COBALT XT DR MRI DF4 GOLD. A total of 6 devices are affected.
These devices may produce reduced or no energy output during high voltage therapy (typically 0-12 joules) due to a defect in a specific glassed feedthrough component. For a device designed to deliver emergency electrical therapy to treat life-threatening heart rhythms, failure to deliver this therapy poses a serious safety risk.
The recall affects devices with the following lot numbers: RSM616778S, RSM610606S, RSM611337S, RSM610608S, RSM611339S, and RSM616777S. These devices have been distributed nationwide and worldwide.
If you have one of these devices, contact your healthcare provider or Medtronic immediately to discuss your device and confirm whether your specific unit is affected.
The recalled product
- Product
- ICD DDPA2D4G COBALT XT DR MRI DF4 GOLD, Model Number DDPA2D4G; Implantable Cardioverter Defibrillators
- Category
- Medical Device — Cardiac Implant
- Affected units
- 6
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 (8)
- GTIN 00763000615628
- Lot Serial Numbers: RSM616778S
- RSM610606S
- RSM611337S
- RSM610608S
- RSM611339S
- GTIN 00763000645502
- Lot Serial Numbers: RSM616777S
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 · device malfunction
See all →- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alert issues
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Convenience Kits Containing CONMED AirSeal Access Ports
FDA (Devices) · 2026-10-21
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 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
- SevereCobalt Implantable Defibrillators May Deliver Reduced Shock Energy
FDA (Devices) · 2022-08-17