Implantable Defibrillator Models May Fail to Deliver Shock Therapy
Medtronic implantable cardiac defibrillators may fail to deliver electrical therapy during treatment due to a defective feedthrough component. Approximately 1,878 devices are affected.
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 classified this as Class I, indicating potential for serious harm. The hazard is failure to deliver life-saving defibrillation therapy when needed. No serious injuries or deaths have been reported in the source text.
Plain-English summary
Medtronic cardiac defibrillator models COBALT HF QUAD MRI IS4 DF1 (Model DTPB2Q1) are subject to recall due to a potential malfunction in energy delivery. These implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) may deliver reduced or no energy output during high-voltage therapy. Approximately 1,878 units have been distributed in the United States and worldwide.
The defect involves a specific glassed feedthrough component used in these devices. In rare cases, this component may not function properly, resulting in reduced or complete loss of electrical energy output when the device attempts to deliver defibrillation therapy. This malfunction could prevent the device from treating dangerous heart rhythms when treatment is needed.
Patients who have received one of these devices should contact their cardiologist or healthcare provider to determine if their device is affected. Discuss with your healthcare provider whether replacement or other management is appropriate. Do not discontinue any prescribed medications or alter normal activities without consulting your healthcare provider.
The recalled product
- Product
- CRTD COBALT HF QUAD MRI IS4 DF1, Model Number DTPB2Q1 ; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- energy-output-failure
- defibrillation-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 (20)
- GTIN 00763000178185
- Lot Serial Numbers: RTL600234S
- RTL600470S
- RTL601046S
- RTL601412S
- RTL601722S
- RTL601669S
- RTL601698S
- RTL600323S
- RTL600660S
- RTL600661S
- RTL601185S
- RTL601206S
- RTL601213S
- RTL601406S
- RTL601445S
- RTL601446S
- RTL600649S
- RTL600650S
- RTL601428S
Distribution
Distributed nationwide across the United States.
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