Medtronic Viva CRT-D Recall for Possible Prevention of Therapy
Medtronic is recalling 951 Viva CRT-D devices due to a potential issue that may prevent high and low voltage therapy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (implantable defibrillator) where the hazard is the potential failure to deliver life-saving therapy, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Medtronic Inc. is recalling 951 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) from the Viva line. The affected devices include specific models such as the Viva Quad S CRT-D DF4, Viva Quad XT CRT-D DF4, Viva S CRT-D DF1, Viva XT CRT-D DF1, and Viva XT CRT-D DF4, along with expanded product numbers. 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 being conducted because of a possible prevention of high and low voltage therapy in the devices. This issue could affect the device's ability to deliver necessary electrical therapy to patients. The devices were distributed nationwide in the United States.
Patients with these specific Medtronic Viva CRT-D devices should contact their healthcare provider or Medtronic for further instructions on how to proceed. The recall covers 951 devices total, with specific serial numbers and UDI codes listed in the official FDA documentation.
The recalled product
- Product
- Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Viva Quad S CRT-D DF4 (Product No. DTBB1QQ); b. Viva Quad XT CRT-D DF4 (Product No. DTBA1QQ); c. Viva S CRT-D DF1 (Product No. DTBB1D1); d. Viva XT CRT-D DF1 (Product No. DT
- Hazard
- 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)
- BLK203257H
- BLK204050H
- BLK204435H)
- BLC205825H
- BLC205826H
- BLC205827H
- BLC206202H
- BLC206263H
- BLC208305H
- BLC208471H
- BLC211869H
- BLC215219H
- BLC215544H
- BLC218906H
- BLC219515H
- BLC220190H
- BLC221044H
- BLC221045H
- BLC221046H
- BLC221047H
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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