Medtronic Recalls Claria MRI CRT-Ds Due to Therapy Prevention Risk
Medtronic is recalling 951 Claria MRI CRT-Ds because a defect may prevent the devices from delivering high or low voltage therapy.
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: The recall is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric, and involves a structural defect in a life-sustaining medical device that could prevent critical therapy.
Plain-English summary
Medtronic Inc. is recalling 951 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) known as Claria MRI. The affected devices are labeled as Claria MRI CRT-D DF1 (Product No. DTMA1D1), Claria MRI Quad CRT-D DF4 (Product No. DTMA1QQ), Claria MRI CRT-D DF4 (Product No. DTMA1D4), and Claria MRI Quad CRT-D DF1 (Product No. DTMA1Q1). These implantable devices are designed to automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia, with some providing resynchronization therapy.
The recall is issued because of a possible prevention of high and low voltage therapy in the devices. This defect could interfere with the device's ability to deliver necessary electrical treatments for heart rhythm issues. The devices were distributed nationwide in the United States.
Patients with these specific devices should contact their healthcare provider or Medtronic for instructions on how to proceed. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following: a. Claria MRI CRT-D DF1 (Product No. DTMA1D1); b. Claria MRI Quad CRT-D DF4 (Product No. DTMA1QQ); EXPANSION: c. Claria MRI CRT-D DF4 (Product No. DTMA1D4); d.…
- Affected units
- 951
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)
- RPT200308H
- RPT201033H
- RPT202625H
- RPT201913H
- RPT202623H
- RPT202624H
- RPT202627H
- RPT202626H)
- 00643169929531 (Serial No. RPT202182H)
- RPA200472H
- RPA200673H
- RPA201732H
- RPA201733H
- RPA202258H
- RPA202454H
- RPA202455H
- RPA202649H
- RPA202650H
- RPA202651H
- RPA202652H
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 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 8 products in this recall →Related recalls
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