The Recall Desk
HighFDA (Devices)·Z-1306-2021·Announced 2021-04-07

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.

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 high-risk medical device (ICD) where a defect could lead to a loss of life-saving therapy (shortened RRT to EOS). Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and it is not an FDA Class I recall.

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)
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category
Medical Device — Implantable Cardioverter Defibrillator
Hazard
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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 2 products in this recall →

Related recalls

Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

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Same hazard · device malfunction

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