Medtronic ICD Devices Potential Energy Output Failure During Therapy
Medtronic's implantable cardioverter defibrillators (ICDs) may produce reduced or no energy output during high voltage therapy due to a feedthrough defect. Patients with affected lot numbers should contact their healthcare provider.
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, the agency's highest classification, indicating a serious health hazard. Although no illnesses or injuries have been reported, the potential for therapy delivery failure in an implanted life-saving cardiac device poses an inherent serious risk.
Plain-English summary
Medtronic Inc. is recalling certain Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices, Model DDPA2D4G COBALT XT DR MRI DF4 GOLD. A total of 6 devices are affected.
These devices may produce reduced or no energy output during high voltage therapy (typically 0-12 joules) due to a defect in a specific glassed feedthrough component. For a device designed to deliver emergency electrical therapy to treat life-threatening heart rhythms, failure to deliver this therapy poses a serious safety risk.
The recall affects devices with the following lot numbers: RSM616778S, RSM610606S, RSM611337S, RSM610608S, RSM611339S, and RSM616777S. These devices have been distributed nationwide and worldwide.
If you have one of these devices, contact your healthcare provider or Medtronic immediately to discuss your device and confirm whether your specific unit is affected.
The recalled product
- Product
- ICD DDPA2D4G COBALT XT DR MRI DF4 GOLD, Model Number DDPA2D4G; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Category
- Medical Device — Cardiac Implant
- Hazard
- device-malfunction
- therapy-failure
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 (8)
- GTIN 00763000615628
- Lot Serial Numbers: RSM616778S
- RSM610606S
- RSM611337S
- RSM610608S
- RSM611339S
- GTIN 00763000645502
- Lot Serial Numbers: RSM616777S
Distribution
Distributed nationwide across the United States.
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