FDA Recall Database: Class I Recall: CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number… by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Key facts

What this classification means

A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class I, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; Implantable Cardioverter Defibrillators should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)’s FDA history

Argus HQ has recorded 120 total FDA actions tied to Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): 0 warning letters, 120 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Is CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; Impla recalled?

Yes. FDA lists a Class I recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) for CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; Implantable Cardioverter Defibrillators, reported 20230628, with status "Ongoing." FDA recall number: Z-1761-2023.

What is the recall class for Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)'s recall?

FDA classified this recall as Class I. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death.

Why was CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; Impla recalled?

FDA's recall record states the reason as: 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.

Who should I contact about this recall?

Contact Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.

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