ICD COBALT XT Defibrillators Recalled for Potential Reduced Energy Output
Medtronic recalled 22,114 ICD COBALT XT defibrillators due to a rare potential for reduced or no energy output during high-voltage therapy delivery caused by a specific feedthrough defect.
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: This recall receives a Class I designation from the FDA, requiring a minimum severity score of 4. Although no illnesses or injuries have been reported, the potential for reduced or complete loss of therapy output in life-critical cardiac devices poses a significant risk of serious harm to affected patients.
Plain-English summary
Medtronic Inc. is recalling 22,114 units of ICD COBALT XT DR MRI IS1 DF4 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) distributed nationwide and worldwide. The devices are identified by model number DDPA2D4 and GTIN 00763000178345 with specific lot serial numbers listed in the recall notice.
The recalled devices were manufactured with a specific glassed feedthrough component that creates a rare potential for reduced or no energy output during high-voltage (HV) therapy, typically in the 0-12 joule range. The FDA has classified this as a Class I recall.
Patients who have received one of the affected devices should contact their healthcare provider to discuss the appropriate course of action. Healthcare providers have information on this recall from Medtronic and the FDA.
The recalled product
- Product
- ICD COBALT XT DR MRI IS1 DF4, Model Number DDPA2D4; Implantable Cardioverter Defibrillators
- Affected units
- 22,114
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 00763000178345
- Lot Serial Numbers: RSM612933S
- RSM612934S
- RSM612935S
- RSM621211S
- RSM604622S
- RSM604623S
- RSM608882S
- RSM621210S
- RSM621212S
- RSM612673S
- RSM609800S
- RSM610899S
- RSM619550S
- RSM620275S
- RSM620130S
- RSM615997S
- RSM619083S
- RSM623383S
- RSM623721S
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.
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