Medtronic Recalls CRT-D Devices Due to Shortened Replacement Time
Medtronic is recalling specific CRT-D implantable cardioverter defibrillators because a small percentage may experience a shortened time before the device reaches end of service.
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: "A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation"
Plain-English summary
Medtronic Inc. is recalling specific models of implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D). The affected devices include the Viva, Claria, Amplia, Compia, and Brava families. A total of 238,393 units were distributed worldwide, including the United States and numerous international markets.
The recall is issued because a small percentage of these implanted devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval. This issue follows an earlier-than-expected RRT observation. The devices are designed to automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia.
Patients with these specific devices should contact their healthcare provider or Medtronic to determine if their device is affected and to discuss appropriate monitoring or replacement options. The recall covers specific serial numbers listed in the official FDA documentation.
The recalled product
- Product
- Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viva S CRT-D, Viva Quad S CRT-D and Viva Quad C CRT-D models; 2) Claria family: Claria MRI CRT-D and Claria MRI Quad CRT-D models; 3)…
- Affected units
- 238,393
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)
- 1) Viva family: MODEL NUMBER / NAME / GTIN: SERIAL NUMBERS BLF244376H
- BLF243732H
- BLF244567H
- BLF243795H
- BLF244186H
- BLF244478H
- BLF243894H
- BLF243453H
- BLF244610H
- BLF244627H
- BLF243514H
- BLF242936H
- BLF244189H
- BLF243735H
- BLF243429H
- BLF244637H
- BLF235234H
- BLF242865H
- BLF243129H
- BLF243389H
Distribution
Part of a larger recall action
This product is one of 2 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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