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.
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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D)."
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.…
- 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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