Implantable Defibrillators May Fail to Deliver Therapeutic Shock
Medtronic implantable cardioverter defibrillators with a specific feedthrough may produce reduced or no energy output during high-voltage therapy, potentially failing to deliver life-saving shocks.
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: This is an FDA Class I recall. Per the severity rubric, FDA Class I recalls never score below 4. The hazard—potential failure of energy output during critical therapy—presents significant risk of patient harm or death if a life-saving defibrillation attempt fails, though no deaths or injuries are reported in the source.
Plain-English summary
Medtronic Inc. has recalled certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), model DTMA2D4 CLARIA MRI OUS DF4. These devices were manufactured with a specific glassed feedthrough that can cause a rare but serious malfunction: reduced or complete loss of energy output during high-voltage (HV) therapy delivery, typically in the 0-12 joule range.
This defect means the device may fail to deliver the therapeutic electrical shock intended to correct life-threatening heart rhythm abnormalities. Approximately 4,593 units of the affected model have been distributed nationwide and worldwide. The recall affects both currently in-use devices and remaining inventory.
Patients with an affected implantable defibrillator should contact their cardiologist or Medtronic immediately to discuss their device and determine whether replacement, repair, or additional monitoring is needed. Do not discontinue use of the device without medical guidance.
The recalled product
- Product
- CRTD DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4; Implantable Cardioverter Defibrillators
- Affected units
- 4,593
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 00643169720664
- Lot Serial Numbers: RPD605666S
- RPD602978S
- RPD602979S
- RPD603034S
- RPD604592S
- RPD601674S
- RPD603271S
- RPD604163S
- RPD605225S
- RPD604970S
- RPD601851S
- RPD602346S
- RPD602637S
- RPD603019S
- RPD605081S
- RPD605207S
- RPD604558S
- RPD604927S
- RPD604980S
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
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FDA (Devices) · 2023-06-28
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