Medtronic Recalls Amplia MRI CRT-D Devices Due to Therapy Prevention Risk
Medtronic is recalling 951 Amplia MRI CRT-D devices because they may fail to deliver 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 involves a Class I FDA classification for a medical device that may fail to deliver life-saving therapy, which meets the criteria for a Severe rating due to the potential for serious injury or death.
Plain-English summary
Medtronic Inc. is recalling 951 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) from the Amplia MRI series. The affected devices are labeled as Amplia MRI CRT-D DF4, Amplia MRI Quad CRT-D DF1, Amplia MRI Quad CRT-D DF4, and Amplia MRI CRT-D DF1. These are implantable devices designed to detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia, with some providing resynchronization therapy.
The recall is issued because the devices may experience a possible prevention of high and low voltage therapy. This means the devices might fail to deliver the necessary electrical shocks or pacing to treat life-threatening heart rhythms.
The devices were distributed nationwide in the United States. Patients with these specific devices should contact their healthcare provider or Medtronic to discuss the risk and determine if a replacement or other corrective action is necessary.
The recalled product
- Product
- Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D DF4 (Product No. DTMB1D4); b. Amplia MRI Quad CRT-D DF1 (Product No. DTMB1Q1); c. Amplia MRI Quad CRT-D DF4 (Product No. DTMB1QQ); EXPANSION: 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)
- a. Product No. DTMB1D4: UDI 00643169543430 (Serial No. RPJ201956H
- RPJ202805H) (EXPANSION: Serial No. RPJ201660H
- RPJ201661H
- RPJ201972H
- RPJ202145H
- RPJ202821H
- RPJ203208H
- RPJ203209H
- RPJ203826H)
- RPU201290H
- RPU201291H
- RPU201292H
- RPU201293H
- RPU201295H
- RPU201296H
- RPU201297H
- RPU201298H
- RPU201299H
- RPU201300H
- RPU201301H
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.
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