Agency classClass IOur severity:Severe FDA (Devices)·Z-1776-2023·Announced 2023-06-28

Medtronic Implantable Defibrillators May Fail Therapy Energy Delivery

Medtronic recalls 3 COBALT XT implantable defibrillators that may deliver reduced or no energy during therapy. A defect in the device feedthrough could prevent effective treatment of abnormal heart rhythms.

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: FDA Class I classification indicates the potential for serious harm. Although no illnesses or injuries are explicitly reported, the risk of therapy failure in an implantable defibrillator during a cardiac emergency represents a life-threatening hazard.

Plain-English summary

Medtronic has recalled the CRTD DTPA2D1PX COBALT XT HF QUAD OUS implantable cardioverter defibrillator (ICD/CRT-D). This recall affects 3 units with lot serial numbers RTH601150S, RTH601151S, and RTH603584S. The devices were distributed nationwide and worldwide.

The recalled defibrillators contain a specific type of feedthrough component that may cause a rare potential for reduced or no-energy output during high voltage therapy, typically delivered at 0-12 joules. If energy output is reduced or absent, the device may not effectively treat abnormal heart rhythms requiring immediate correction.

Patients who have received one of the affected devices should contact Medtronic and their healthcare provider immediately to discuss options. The FDA issued a Class I recall, the highest severity level, due to the potential for serious harm if the device fails to deliver therapy during a cardiac event.

The recalled product

Product: CRTD DTPA2D1PX COBALT XT HF QUAD OUS, Model Number DTPA2D1PX; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable Cardiovascular Devices
Hazard: reduced-energy-output
therapy-failure
Affected units: 3

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 (5)

GTIN 00763000446048
lot serial Numbers: RTH601150S
RTH601151S
GTIN 00763000718732
Lot Serial Numbers: RTH603584S

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

Same hazard · reduced energy output