Agency classClass IOur severity:Severe FDA (Devices)·Z-1734-2023·Announced 2023-06-28

Medtronic Implantable Cardioverter Defibrillators Recalled for Reduced Therapy Output

Medtronic is recalling 14 units of CRTD VIVA QUAD XT implantable cardioverter defibrillators due to rare potential for reduced or no energy output during high voltage therapy. Affected devices were manufactured with a specific feedthrough defect.

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 designation requires minimum severity of 4 (Severe). The defect affects a life-critical implantable cardiac device where failure to deliver therapy could have serious health consequences, though no illnesses or injuries have been reported in the source material.

Plain-English summary

Medtronic Inc. is recalling 14 units of the CRTD VIVA QUAD XT CUST PARY GOLD implantable cardioverter defibrillators (Model DTBA1QQPG). These are life-sustaining devices implanted in cardiac patients to regulate abnormal heart rhythms and deliver therapy when needed.

The recall is due to a rare potential for reduced or no energy output during high voltage (HV) therapy (typically 0-12 joules) in devices manufactured with a specific glassed feedthrough. This defect could impair the device's ability to deliver therapy when required.

The affected devices have US nationwide and worldwide distribution. Affected lot serial numbers are: BLC229283H, BLC229226H, BLC229270H, BLC229280H, BLC229229H, BLC228997H, BLC229238H, BLC229043H, BLC229231H, BLC229046H, BLC229045H, BLC229230H, BLC228995H, and BLC229010H.

The recalled product

Product: CRTD VIVA QUAD XT CUST PARY GOLD, Model Number DTBA1QQPG; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable Cardiac Device
Hazard: device-malfunction
energy-output-failure
Affected units: 14

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 (15)

GTIN 00643169968585
Lot Serial Numbers: BLC229283H
BLC229226H
BLC229270H
BLC229280H
BLC229229H
BLC228997H
BLC229238H
BLC229043H
BLC229231H
BLC229046H
BLC229045H
BLC229230H
BLC228995H
BLC229010H

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
Critical
Medtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
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
Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28

Same hazard · device malfunction