FDA (Devices) recall action 92328

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalled 120 products on 2023-06-28

The FDA (Devices) publishes a recall like this one as 120 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 120 pages.

Products: 120
Announced: 2023-06-28
Critical: 6
Units: 810,580

Why these products were recalled

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 a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–25 of 120

SevereFDA (Devices)··2023-06-28
Medtronic Implantable Cardioverter Defibrillators Recalled for Potential Therapy Failure
Medtronic is recalling 661 CRT-D implantable defibrillators due to a rare manufacturing defect that may reduce or eliminate energy output during therapy delivery. Affected devices may fail to deliver necessary electrical treatment during cardiac emergencies.
Product
CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4; Implantable Cardioverter Defibrillators
Category
Distribution
0 states
SevereFDA (Devices)··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
Distribution
0 states
SevereFDA (Devices)··2023-06-28
Implantable defibrillators may fail to deliver high-voltage therapy during treatment
Certain Medtronic ICD and CRT-D devices with a specific feedthrough may fail to deliver energy during high-voltage therapy. This rare defect affects 9,325 units worldwide and could compromise cardiac protection.
Product
ICD COBALT XT VR MRI DF4, Model Number DVPA2D4; Implantable Cardioverter Defibrillators
Category
Distribution
0 states
SevereFDA (Devices)··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
Distribution
0 states
SevereFDA (Devices)··2023-06-28
Implantable Cardioverter Defibrillators May Fail to Deliver High-Voltage Therapy
Certain Medtronic implantable cardioverter defibrillators manufactured with a specific feedthrough may produce reduced or no energy output during high-voltage therapy, potentially compromising treatment effectiveness.
Product
ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; Implantable Cardioverter Defibrillators
Category
Distribution
0 states
SevereFDA (Devices)··2023-06-28
Medtronic Implantable Cardiac Defibrillators Risk Therapy Delivery Failure
Medtronic is recalling certain CRT-D and ICD models due to a potential feedthrough defect that may prevent energy delivery during high-voltage therapy. The FDA Class I recall affects 435 units distributed in the United States and worldwide.
Product
CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; Implantable Cardioverter Defibrillators
Category
Distribution
0 states
SevereFDA (Devices)··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
Distribution
0 states
SevereFDA (Devices)··2023-06-28
Implantable Cardioverter Defibrillators May Fail During High-Voltage Therapy
Medtronic recalls implantable cardioverter defibrillators due to rare potential for reduced or no-energy output during high-voltage therapy, which could prevent life-saving defibrillation.
Product
ICD-VR DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4; Implantable Cardioverter Defibrillators
Category
Distribution
0 states
SevereFDA (Devices)··2023-06-28
Implantable Defibrillators May Fail to Deliver Energy During Therapy
Medtronic implantable cardioverter defibrillators (CRT-Ds) may fail to deliver adequate energy during high-voltage treatment due to a manufacturing defect in the feedthrough component, affecting 373 units.
Product
CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1; Implantable Cardioverter Defibrillators
Category
Distribution
0 states
SevereFDA (Devices)··2023-06-28
Implantable Cardioverter Defibrillators Risk Reduced Energy Output During Therapy
Medtronic's implantable cardioverter defibrillators may produce reduced or no energy during high voltage therapy due to a feedthrough defect. A total of 1,076 units are affected worldwide.
Product
CRT-D DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1; Implantable Cardioverter Defibrillators
Category
Distribution
0 states
SevereFDA (Devices)··2023-06-28
Medtronic implantable cardioverter defibrillators recalled for potential reduced-output defect
Medtronic has recalled certain ICD and CRT-D cardiac devices due to a rare risk of reduced or no energy output during high-voltage therapy. The affected models contain a specific glassed feedthrough component.
Product
ICD-VR DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4; Implantable Cardioverter Defibrillators
Category
Distribution
0 states
SevereFDA (Devices)··2023-06-28
Implantable Cardiac Defibrillators at Risk of Therapy Delivery Failure
Medtronic implantable defibrillators may fail to deliver therapy due to a feedthrough defect. 2,173 affected units were distributed nationwide and worldwide.
Product
CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1; Implantable Cardioverter Defibrillators
Category
Distribution
0 states
SevereFDA (Devices)··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
Distribution
0 states
SevereFDA (Devices)··2023-06-28
Implantable cardiac defibrillators recalled for potential therapy failure risk
Medtronic recalls ICD COBALT VR MRI DF4 defibrillators due to a rare potential for reduced or no energy output during high-voltage therapy. The defect affects devices manufactured with a specific glassed feedthrough component.
Product
ICD COBALT VR MRI DF4, Model Number DVPB3D4; Implantable Cardioverter Defibrillators
Category
Distribution
0 states
SevereFDA (Devices)··2023-06-28
Implantable Defibrillators Risk Reduced Energy Output During Therapy
Medtronic implantable defibrillators with a specific feedthrough may fail to deliver adequate energy during high voltage therapy. Approximately 476 affected units distributed nationwide and worldwide.
Product
CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter Defibrillators
Category
Distribution
0 states
CriticalFDA (Devices)··2023-06-28
Medtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
Medtronic implantable cardioverter defibrillators (CRT-D) may deliver reduced or no energy during high-voltage therapy due to manufacturing defect in the feedthrough component. FDA Class I recall affects 182 units.
Product
CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4; Implantable Cardioverter Defibrillators
Category
Distribution
0 states
SevereFDA (Devices)··2023-06-28
Implantable Defibrillators With Defective Feedthrough May Fail to Deliver Therapy
Certain Medtronic implantable defibrillators may produce reduced or no energy output during high-voltage therapy due to a defective feedthrough component affecting 71 units.
Product
ICD-VR VISIA AF XT OUS IS1/DF1, Model Number DVAB2D1; Implantable Cardioverter Defibrillators
Category
Distribution
0 states
SevereFDA (Devices)··2023-06-28
Implantable Defibrillators With Defective Feedthrough May Fail During Critical Therapy
Medtronic is recalling 14,270 implantable cardioverter defibrillators with a specific feedthrough that may produce reduced or no energy output during high-voltage therapy. The affected devices may fail to deliver critical treatment when needed.
Product
ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; Implantable Cardioverter Defibrillators
Category
Distribution
0 states
SevereFDA (Devices)··2023-06-28
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.
Product
ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; Implantable Cardioverter Defibrillators
Category
Distribution
0 states
SevereFDA (Devices)··2023-06-28
Medtronic Implantable Defibrillators May Fail to Deliver Therapy
Medtronic is recalling certain implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators due to a rare risk of reduced or no energy output during high voltage therapy.
Product
CRTD DTBA2D1G VIVA XT IS1 DF1 OUS GOLD, Model Number DTBA2D1G; Implantable Cardioverter Defibrillators
Category
Distribution
0 states
SevereFDA (Devices)··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
Distribution
0 states
SevereFDA (Devices)··2023-06-28
Implantable Cardioverter Defibrillators Risk Reduced Energy Output During Therapy
Medtronic is recalling 522 implantable cardioverter defibrillators that may deliver reduced or no energy during high-voltage therapy due to a feedthrough defect.
Product
ICD-DR DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4; Implantable Cardioverter Defibrillators
Category
Distribution
0 states
SevereFDA (Devices)··2023-06-28
Medtronic CRT-D Implants Recalled for Rare Energy Output Failure Risk
Medtronic is recalling certain CRT-D (cardiac resynchronization therapy defibrillator) models due to a rare risk of reduced or no energy output during high-voltage therapy. The FDA has classified this as a Class I recall affecting 1,473 units.
Product
CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; Implantable Cardioverter Defibrillators
Category
Distribution
0 states
CriticalFDA (Devices)··2023-06-28
Medtronic Implantable Cardioverter Defibrillators Recalled for Potential Therapy Failure
Medtronic's ICD COBALT defibrillators may fail to deliver critical therapy due to a manufacturing defect in a power delivery component. Patients should contact their physician to determine if affected.
Product
ICD COBALT DR MRI IS1 DF1, Model Number DDPB3D1; Implantable Cardioverter Defibrillators
Category
Distribution
0 states
SevereFDA (Devices)··2023-06-28
Medtronic Implantable Cardioverter Defibrillators Recalled for Reduced Therapy Output
Medtronic is recalling 14 units of CRTD VIVA QUAD XT implantable cardioverter defibrillators due to rare potential for reduced or no energy output during high voltage therapy. Affected devices were manufactured with a specific feedthrough defect.
Product
CRTD VIVA QUAD XT CUST PARY GOLD, Model Number DTBA1QQPG; Implantable Cardioverter Defibrillators
Category
Distribution
0 states