Medtronic Recalls Compia MRI CRT-Ds Due to Therapy Prevention Risk
Medtronic is recalling 951 Compia MRI CRT-Ds because a defect may prevent the delivery of high and 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 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: The source identifies the recall as FDA Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Medtronic Inc. is recalling 951 units of the Compia MRI Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). The affected devices are labeled as Compia MRI CRT-D DF1 (Product No. DTMC1D1) and Compia MRI Quad CRT-D DF4 (Product No. DTMC1QQ). These are implantable devices 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. This defect could prevent the device from delivering 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 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 the death.
The recalled product
- Product
- Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the following: a. Compia MRI CRT-D DF1 (Product No. DTMC1D1); b. Compia MRI Quad CRT-D DF4 (Product No.DTMC1QQ ) Implantable devices that automatically detect and treat episodes of…
- 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 (10)
- a. Product No. DTMC1D1: UDI 00643169705807 (Serial No. RPW200289H)
- RPL200534H
- RPL201039H
- RPL201059H
- RPL201235H
- RPL201236H
- RPL201454H
- RPL201645H
- RPL201664H
- RPL201234H)
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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