Agency classClass IOur severity:Severe FDA (Devices)·Z-1788-2023·Announced 2023-06-28

Medtronic Implantable Cardioverter Defibrillators May Deliver Reduced Energy During High Voltage Therapy

Certain Medtronic implantable cardioverter defibrillators may deliver reduced or no energy during high-voltage therapy. Approximately 2,142 affected units have been identified.

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 medical device recall. Per FDA classification standards, Class I recalls score a minimum of 4 (Severe) as they indicate a product with serious health risks. The recalled devices may fail to deliver critical high-voltage therapy.

Plain-English summary

Medtronic Inc. is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), model DTPC2QQ, due to a rare potential for reduced or no-energy output during high-voltage therapy (typically 0-12 joules). The issue is associated with a specific glassed feedthrough component found in these devices.

Approximately 2,142 units have been identified in the recall. These devices have been distributed nationwide and worldwide, including currently available units and previously implanted devices.

Patients with these devices should contact Medtronic Inc. for information and guidance regarding this recall.

The recalled product

Product: CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Cardiac Defibrillator
Hazard: device-malfunction
energy-output-failure
Affected units: 2,142

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 00763000178253
Lot Serial Numbers: RTS600109S
RTS600115S
RTS600751S
RTS600754S
RTS600962S
RTS600827S
RTS600976S
RTS600761S
RTS600116S
RTS600128S
RTS600174S
RTS600280S
RTS600285S
RTS600674S
RTS600094S
RTS600271S
RTS600277S
RTS600961S
RTS600987S

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 →

Severe
Implantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
Severe
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 · device malfunction