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.
What this means for you
Illness, injury, or structural failure has been reported. 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)
- Hazard
- reduced-energy-output
- therapy-failure
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.
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