Agency classClass IOur severity:Severe FDA (Devices)·Z-1807-2023·Announced 2023-06-28

Medtronic Implantable Cardioverter Defibrillator may lose energy output during therapy

Medtronic recalls approximately 5,622 implantable cardioverter defibrillators that may produce reduced or no energy output during high-voltage therapy due to a specific feedthrough component defect.

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 for an implanted cardiac device with a rare but serious potential defect that could prevent delivery of life-saving therapy. Although no adverse events have been reported, the risk to patients is significant.

Plain-English summary

Medtronic is recalling approximately 5,622 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), including model DVFC3D1. The devices were manufactured with a specific glassed feedthrough component.

There is a rare potential for reduced or no energy output during high-voltage therapy (typically 0-12J) in these devices. This could prevent the device from delivering necessary therapy during critical cardiac events.

The affected devices have been distributed nationwide in the United States and worldwide. A complete list of affected lot serial numbers is available in the FDA recall notice.

The recalled product

Product: ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable Cardiac Device
Hazard: reduced-energy-output
therapy-failure
Affected units: 5,622

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 00643169837812
Lot Serial numbers: CWJ604194S
CWJ604707S
CWJ604057S
CWJ602128S
CWJ604288S
CWJ602870S
CWJ601914S
CWJ603587S
CWJ603802S
CWJ601000S
CWJ601001S
CWJ601158S
CWJ601706S
CWJ601799S
CWJ601845S
CWJ604343S
CWJ604387S
CWJ601910S
CWJ603379S

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 →

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

See all →

Severe
Medtronic Implantable Cardioverter Defibrillators Recalled for Reduced Therapy Output
FDA (Devices) · 2023-06-28
Critical
Medtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
FDA (Devices) · 2023-06-28
Severe
Medtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
FDA (Devices) · 2023-06-28
Severe
Implantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
Severe
Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28

Same hazard · reduced energy output