Medtronic Implantable Defibrillators May Fail to Deliver Therapy
Certain Medtronic ICDs manufactured with a specific feedthrough may fail to deliver high-voltage therapy. Patients should contact their healthcare provider immediately.
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 classification requires a minimum severity score of 4. No illnesses or injuries have been reported. The hazard involves potential failure of a critical cardiac therapy function.
Plain-English summary
Medtronic is recalling certain Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) models manufactured with a specific glassed feedthrough. The EVERA S IS1/DF1 model (DDBC3D1) is the subject of this recall, affecting approximately 5,176 units distributed nationwide and internationally.
These devices carry a rare potential for reduced or completely absent energy output during high-voltage (HV) therapy, typically at 0-12 joules. If this malfunction occurs, the device may fail to deliver necessary therapy when needed to restore a normal heart rhythm during a cardiac emergency.
Patients with affected devices should contact their healthcare provider or Medtronic immediately to discuss evaluation options and potential device management. Healthcare providers have been notified of this recall and specific lot serial numbers have been identified. Patients should check their device documentation to determine if their device is included in this recall.
The recalled product
- Product
- ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; Implantable Cardioverter Defibrillators
- Affected units
- 5,176
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 00643169720411
- Lot Serial Numbers: BWG208720H
- BWG208284H
- BWG208405H
- BWG208608H
- BWG208700H
- BWG208763H
- BWG208301H
- BWG208376H
- BWG208406H
- BWG208412H
- BWG208520H
- BWG208539H
- BWG208652H
- BWG208716H
- BWG208296H
- BWG208340H
- BWG208484H
- BWG208220H
- BWG208234H
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 · therapy failure
See all →- HighImplantable Vagus Nerve Stimulation Device May Stop Delivering Therapy
FDA (Devices) · 2025-02-05
- HighV.A.C. Ulta Therapy Units Recalled Due to Occlusion Sensor Failures
FDA (Devices) · 2024-12-04
- HighReplacement Lead Wires Recalled for Risk of Treatment Delivery Failure
FDA (Devices) · 2024-05-01
- HighOPTIMIZER CCM X11 Implantable Pulse Generator May Fail to Deliver Therapy
FDA (Devices) · 2024-02-28
- SeverePercussionaire Distal Phasitron respiratory device with reservoir bag assembly defect recalled
FDA (Devices) · 2024-01-24
Similar recalls
- CriticalMedtronic Recalls Evera ICDs Due to Possible Therapy Prevention
FDA (Devices) · 2018-02-28
- SevereMedtronic Visia AF ICDs Recalled for Potential Therapy Failure
FDA (Devices) · 2018-02-28
- SevereCobalt Implantable Cardioverter Defibrillators May Deliver Reduced Shock Energy
FDA (Devices) · 2022-08-17
- HighMedtronic EVERA S VR Implantable Cardioverter Defibrillator Recalled for Manufacturing Defect
FDA (Devices) · 2024-07-03
- SevereCobalt Implantable Cardioverter Defibrillators recalled for reduced shock energy
FDA (Devices) · 2022-08-17
- SevereMedtronic EnTrust ICD Recall for Potential Loss of High Voltage Therapy
FDA (Devices) · 2018-07-18