Implantable Cardioverter Defibrillators Risk Therapy Failure Due to Feedthrough Defect
Medtronic implantable cardioverter defibrillators may fail to deliver critical therapy due to a feedthrough defect. The defect can cause reduced or absent energy output during high-voltage therapy in 8,602 affected units distributed worldwide.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I classification. The defect creates potential for complete device malfunction during critical therapy, preventing delivery of life-saving electrical treatment for dangerous heart rhythms.
Plain-English summary
Medtronic is recalling approximately 8,602 units of the CRTD DTMA1Q1 CLARIA MRI QUAD US DF1 model implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The devices were manufactured with a specific glassed feedthrough component that can result in rare instances of reduced or absent energy output during high-voltage therapy delivery.
Implantable cardioverter defibrillators and CRT-Ds are critical life-saving devices designed to monitor heart rhythm and deliver electrical therapy to prevent sudden cardiac death. When functioning properly, these devices provide essential treatment for dangerous heart rhythms. A failure to deliver adequate therapy energy represents a serious functional defect that could prevent life-saving treatment.
Affected devices have been distributed in the United States and worldwide. Patients should not discontinue use of their devices without consulting their healthcare provider, as removal of a functioning ICD poses greater health risk. Patients with these devices should contact their physician or Medtronic to determine if their device is affected based on the lot serial numbers provided in the recall notice.
The recalled product
- Product
- CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardioverter Defibrillators
- Affected units
- 8,602
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 00643169837669
- Lot Serial numbers: RPS205974H
- RPS208665H
- RPS206712H
- RPS207744H
- RPS205038H
- RPS205791H
- RPS206225H
- RPS208216H
- RPS206084H
- RPS203804H
- RPS208198H
- RPS208245H
- RPS205937H
- RPS205565H
- RPS206114H
- RPS206723H
- RPS206730H
- RPS206733H
- RPS206734H
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 →Related recalls
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