Manufacturer

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

198 recalls in our database name Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) as the manufacturing or recalling firm.

What the numbers show

Total: 198
Critical: 8
Severe: 126
Most recent: 2023-06-28

Of the 198 recalls from Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) we have scored against our rubric, 8 (4%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 126 (64%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 198

SevereFDA (Devices)·Z-1714-2023·2023-06-28
Implantable Cardioverter Defibrillators Recalled for Potential Reduced Energy Output
Medtronic implantable cardioverter defibrillators (ICDs) and CRT-Ds with specific feedthrough designs may produce reduced or insufficient energy during high voltage therapy, affecting the device's ability to treat heart arrhythmias.
Product
ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1767-2023·2023-06-28
Implantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
Certain Medtronic implantable cardioverter defibrillators may fail to deliver high-voltage therapy due to a specific feedthrough defect. The 4,767 affected units were distributed nationwide and worldwide.
Product
CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1753-2023·2023-06-28
Implantable Defibrillators May Fail to Deliver High-Voltage Therapy Energy
Certain Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during therapy due to a feedthrough defect. Approximately 11,794 units worldwide are affected.
Product
CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1773-2023·2023-06-28
Implantable Defibrillators May Fail to Deliver Critical Therapy
Medtronic implantable defibrillators may produce reduced or no energy output during high-voltage therapy delivery. Affected devices were manufactured with a specific feedthrough component.
Product
CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1716-2023·2023-06-28
Medtronic Implantable Cardioverter Defibrillators Recalled for Potential Energy Output Failure
Medtronic is recalling certain implantable cardioverter defibrillators and cardiac resynchronization therapy devices due to a rare potential for reduced or no energy output during high voltage therapy. Approximately 37,547 units are affected.
Product
ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1727-2023·2023-06-28
Implantable cardioverter defibrillators may output reduced or no energy during therapy
Medtronic ICDs and CRT-Ds with specific feedthroughs may fail to deliver adequate high-voltage therapy. This FDA Class I recall affects 487 units distributed nationwide and worldwide.
Product
ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1816-2023·2023-06-28
Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
Medtronic recalls certain ICD and CRT-D defibrillators due to a rare potential for reduced or no-energy output during high-voltage therapy. Affected devices were manufactured with a specific glassed feedthrough component.
Product
ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1737-2023·2023-06-28
Medtronic Implantable Heart Defibrillators Risk Therapy Delivery Failure
Medtronic CRT-D and ICD implantable defibrillators may fail to deliver therapy due to a rare defect in a specific feedthrough component. The recalled devices carry a potential for reduced or no-energy output during high-voltage heart rhythm treatment.
Product
CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1774-2023·2023-06-28
Implantable Cardioverter Defibrillators May Fail During High-Voltage Therapy
Some Medtronic implantable defibrillators contain a specific feedthrough that may rarely cause reduced or no energy output during high-voltage therapy. The recall affects approximately 4,151 units distributed nationwide.
Product
CRTD COBALT XT HF MRI IS1 DF1, Model Number DTPA2D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1805-2023·2023-06-28
Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output
Medtronic ICDs and CRT-Ds with a specific feedthrough defect may produce reduced or no energy output during high-voltage therapy. The recall involves approximately 4,546 units distributed nationwide and worldwide.
Product
ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1777-2023·2023-06-28
Implantable Defibrillators Recalled for Rare Risk of Energy Output Failure
Medtronic implantable defibrillators may deliver reduced or no energy during therapy due to a rare electrical defect. Approximately 1,914 units with a specific feedthrough component are affected and distributed worldwide.
Product
CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1740-2023·2023-06-28
Implantable Defibrillators Risk Loss of Therapy from Feedthrough Defect
Medtronic recalls certain CRT-D VIVA QUAD XT GOLD implantable defibrillators due to a rare risk of reduced or no electrical output during therapy. Affected devices contain a specific glassed feedthrough component.
Product
CRT-D VIVA QUAD XT GOLD CTD, Model Number DTBA2QQG; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1733-2023·2023-06-28
Medtronic CRT-D and ICD Defibrillators Recalled for Potential Therapy Output Failure
Medtronic has recalled 891 implantable cardioverter defibrillators (CRT-D) worldwide due to a rare potential for reduced or absent energy output during defibrillation therapy. Units manufactured with a specific feedthrough component are affected.
Product
CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US, Model Number DTBA1QQ; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1808-2023·2023-06-28
Implantable Cardioverter Defibrillators May Fail During High Voltage Therapy
Medtronic implantable cardioverter defibrillators may fail to deliver therapy due to a defect in the electrical feedthrough. The devices risk reduced or no energy output during high-voltage treatment.
Product
ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1782-2023·2023-06-28
Implantable Defibrillators May Fail During High-Voltage Cardiac Therapy
Medtronic implantable defibrillators may fail to deliver energy during high-voltage cardiac therapy due to a defective glassed feedthrough component. The recall affects 2,968 units distributed nationwide and worldwide.
Product
CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1720-2023·2023-06-28
Implantable Cardioverter Defibrillators May Fail to Deliver High Voltage Therapy
Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during high voltage therapy due to a specific feedthrough manufacturing defect. Approximately 8,219 units were affected worldwide.
Product
ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1803-2023·2023-06-28
Implantable Cardioverter Defibrillators Recalled for Potential High Voltage Therapy Failure
Medtronic implantable cardioverter defibrillators (ICDs) with a specific feedthrough component may have reduced or absent energy output during high voltage therapy. The FDA Class I recall affects 12,099 units distributed nationwide and worldwide.
Product
ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1813-2023·2023-06-28
Implantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
Medtronic implantable defibrillators may fail to deliver therapy during critical cardiac events due to a feedthrough defect. Approximately 25,058 units are affected nationwide and worldwide.
Product
ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1799-2023·2023-06-28
Implantable Cardioverter Defibrillators Recalled for Potential Energy Output Failure
Medtronic's implantable cardioverter defibrillators may fail to deliver high-voltage therapy due to a feedthrough defect. Approximately 6,821 devices are affected worldwide.
Product
ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1771-2023·2023-06-28
Medtronic implantable defibrillators may fail to deliver therapy
Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators with specific feedthrough components may fail to deliver adequate high-voltage therapy output.
Product
CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1728-2023·2023-06-28
Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
Medtronic is recalling certain ICD and CRT-D devices that may fail to deliver high-voltage therapy due to a manufacturing defect in the device feedthrough. The recall affects 2,018 units distributed nationwide and worldwide.
Product
ICD CROME DR MRI IS1 DF4, Model Number DDPC3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1778-2023·2023-06-28
Implantable Defibrillators May Deliver Reduced Energy During Therapy
Medtronic ICDs and CRT-Ds with a specific feedthrough may deliver reduced or no energy during high voltage therapy. Approximately 2,669 units are affected in the US and worldwide.
Product
CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1792-2023·2023-06-28
Medtronic ICD defibrillators may fail to deliver critical therapy
Medtronic recalled certain implantable defibrillators that may fail to deliver electrical therapy during critical heart rhythm events due to a manufacturing defect in the device feedthrough.
Product
ICD-VR VISIA AF XT OUS DF4, Model Number DDVAB2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1766-2023·2023-06-28
Implantable defibrillators may deliver reduced or no energy during therapy
Medtronic implantable defibrillators and cardiac resynchronization devices with a specific glassed feedthrough may fail to deliver full energy during therapy. Approximately 8,575 units affected worldwide.
Product
CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1707-2023·2023-06-28
Implantable Defibrillators Risk Reduced or No Energy Output During Therapy
Certain Medtronic implantable defibrillators may fail to deliver high voltage therapy due to a feedthrough defect. The FDA Class I recall affects 2,282 units distributed nationwide and worldwide.
Product
ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide