Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
Medtronic is recalling 289 implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators due to a rare potential defect that may prevent proper high-voltage therapy delivery.
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 establishes a minimum severity of 4 per the rubric. Although no illnesses or injuries have been reported, the potential for therapy failure in an implanted cardiac device that prevents life-saving defibrillation justifies this severe rating.
Plain-English summary
Medtronic has recalled 289 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), model DVEX3E4, due to a potential defect in a specific glassed feedthrough component.
The defect creates a rare potential that the device may produce reduced or no energy output during high-voltage (HV) therapy, typically in the 0-12 joule range. This could prevent the device from delivering the intended electrical therapy to restore normal heart rhythm during cardiac events.
The affected devices were distributed nationwide in the United States and worldwide. Patients with affected ICDs or CRT-Ds are potentially at risk of inadequate therapy delivery in the event of a cardiac arrhythmia requiring defibrillation.
Patients who have received an affected device should contact their healthcare provider to discuss their individual risk and appropriate management options.
The recalled product
- Product
- ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardioverter Defibrillators
- Affected units
- 289
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 00763000217891
- Lot Serial Numbers: EVS600719S
- EVS600271S
- EVS600272S
- EVS600273S
- EVS600274S
- EVS600322S
- EVS600324S
- EVS600325S
- EVS600326S
- EVS600366S
- EVS600372S
- EVS600503S
- EVS600504S
- EVS600529S
- EVS600530S
- EVS600531S
- EVS600547S
- EVS600548S
- EVS600623S
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
- HighExtravascular defibrillators recalled over potential delay in high-voltage therapy delivery
FDA (Devices) · 2025-12-10
- SevereMedtronic Visia AF ICDs Recalled for Potential Therapy Failure
FDA (Devices) · 2018-02-28
- SevereMedtronic EnTrust ICD Recall for Potential Loss of High Voltage Therapy
FDA (Devices) · 2018-07-18
- CriticalMedtronic Recalls Evera ICDs Due to Possible Therapy Prevention
FDA (Devices) · 2018-02-28
- HighMedtronic Implantable Cardioverter Defibrillator Recalled for Manufacturing Weld Defect
FDA (Devices) · 2024-07-03
- SevereCrome Implantable Cardioverter Defibrillators Recalled for Reduced Shock Energy
FDA (Devices) · 2022-08-17