Implantable Cardioverter Defibrillators May Fail to Deliver Therapy
3,570 implantable cardioverter defibrillators and cardiac resynchronization defibrillators with a specific feedthrough defect may fail to deliver high-voltage therapy when needed.
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 classification requires minimum Severe severity. An implantable cardioverter defibrillator failure to deliver high-voltage therapy during cardiac events presents serious risk to patient safety, though no illnesses or injuries are reported in the source.
Plain-English summary
Medtronic Inc. is recalling 3,570 CRTD DTMA2D1 CLARIA MRI OUS DF1 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) due to a rare potential for reduced or no-energy output during high-voltage therapy delivery.
The affected devices contain a specific glassed feedthrough component. These devices may fail to deliver proper energy during high-voltage therapy at typical levels of 0-12 joules. Affected devices have been distributed nationwide and worldwide.
The recalled product
- Product
- CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- therapy-failure
- device-defect
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 00643169837621
- Lot Serial Numbers: RPO604357S
- RPO603344S
- RPO603999S
- RPO603613S
- RPO602588S
- RPO603485S
- RPO603586S
- RPO603863S
- RPO601733S
- RPO603715S
- RPO601235S
- RPO601389S
- RPO601698S
- RPO601771S
- RPO602006S
- RPO602325S
- RPO602359S
- RPO602456S
- RPO602547S
Distribution
Distributed nationwide across the United States.
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