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.
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 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
- Affected units
- 3,570
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.
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)
See all →- SevereImplantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
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- SevereImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output
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