Agency classClass IOur severity:Severe FDA (Devices)·Z-1723-2023·Announced 2023-06-28

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.

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 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
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable Cardiovascular Device
Hazard: therapy-failure
device-malfunction
reduced-energy-output
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.

See all 120 products in this recall →

Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

See all →

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Implantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
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Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
Severe
Medtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
FDA (Devices) · 2023-06-28
Severe
Medtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28
Severe
Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28

Same hazard · therapy failure