Agency classClass IOur severity:Severe FDA (Devices)·Z-1739-2023·Announced 2023-06-28

Implantable Cardioverter Defibrillators Risk Energy Output Failure

Medtronic Inc. is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) due to a rare potential for reduced or no-energy output during high voltage therapy. Affected devices contain a specific glassed feedthrough.

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 mandates a minimum Severe rating. Although no injuries or deaths are reported in the source, the potential for complete treatment failure in a critical implantable cardiac device justifies this severity level.

Plain-English summary

Medtronic Inc. is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), model DTBA2QQ VIVA QUAD XT, that were manufactured with a specific glassed feedthrough. The recall affects 2,931 units distributed nationwide and worldwide.

The recalled devices carry a rare potential for reduced or no-energy output during high voltage (HV) therapy, typically in the 0-12J energy range. This malfunction could prevent the device from delivering appropriate shock therapy when medically necessary.

Patients with affected devices should contact their healthcare provider or cardiologist to verify whether their device is included in this recall. Medtronic has identified specific lot serial numbers to facilitate identification.

The recalled product

Product: CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable Cardiac Defibrillators
Hazard: device-malfunction
reduced-energy-output
Affected units: 2,931

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 00643169720169
Lot Serial Numbers: BLG624311S
BLG624755S
BLG625177S
BLG625181S
BLG625182S
BLG625188S
BLG625193S
BLG625324S
BLG625325S
BLG625434S
BLG625596S
BLG625598S
BLG625606S
BLG625608S
BLG625636S
BLG625647S
BLG625702S
BLG625740S
BLG625741S

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
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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 · device malfunction