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
- 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 →Related recalls
Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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