Implantable Defibrillators Risk Reduced Energy Output During Therapy
Medtronic implantable defibrillators with a specific feedthrough may fail to deliver adequate energy during high voltage therapy. Approximately 476 affected units distributed nationwide and worldwide.
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 affecting implantable cardioverter defibrillators, which are life-sustaining devices for cardiac patients. The potential for device malfunction during critical high-voltage therapy poses significant risk of serious patient harm, warranting a Severe classification under FDA Class I standards.
Plain-English summary
Medtronic Inc. is recalling specific manufacturing lots of CRTD CROME HF MRI IS1 DF4 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), Model Number DTPC2D4. A total of 476 units are affected. These devices are implanted in patients to monitor heart rhythm and deliver electrical therapy to restore normal heartbeat when life-threatening arrhythmias occur.
Devices manufactured with a specific glassed feedthrough component have a rare potential for reduced or no energy output during high voltage therapy, typically at 0-12 joules. This malfunction could prevent the device from delivering necessary life-saving therapy at the moment it is needed.
The affected devices have been distributed nationwide in the United States and internationally. Specific manufacturing lots have been identified with detailed serial numbers provided to healthcare providers and manufacturers. Patients with implanted devices should contact their healthcare provider or Medtronic to determine if their device is among those affected.
Patients should not attempt self-management of this issue. Healthcare providers should evaluate affected patients and work with Medtronic regarding appropriate clinical management, which may include device replacement, enhanced monitoring, or other therapeutic measures.
The recalled product
- Product
- CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter Defibrillators
- Affected units
- 476
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 00763000178291
- Lot Serial numbers: RTW600585S
- RTW600307S
- RTW600091S
- RTW600313S
- RTW600121S
- RTW600342S
- RTW600596S
- RTW600074S
- RTW600144S
- RTW600102S
- RTW600319S
- RTW600578S
- RTW600346S
- RTW600277S
- RTW600309S
- RTW600581S
- RTW600098S
- RTW600118S
- RTW600119S
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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See all →- SevereImplantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
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