Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1 Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Due to There is a rare potential for reduced- or...

Date: May 10, 2023
Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) directly.

Affected Products

CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; Implantable Cardioverter Defibrillators

Quantity: 1658 units

Why Was This Recalled?

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 198 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report