The Recall Desk
SevereFDA (Devices)·Z-1731-2023·Announced 2023-06-28

Medtronic Implantable Cardioverter Defibrillators Recalled for Potential Therapy Failure

Medtronic is recalling 661 CRT-D implantable defibrillators due to a rare manufacturing defect that may reduce or eliminate energy output during therapy delivery. Affected devices may fail to deliver necessary electrical treatment during cardiac emergencies.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I designation mandates a minimum severity rating of 4. The recalled implantable defibrillators pose a risk of therapeutic failure in life-threatening cardiac situations. Although no illnesses or injuries are explicitly reported in the source, the potential for device failure to deliver life-saving therapy is inherently serious.

Plain-English summary

Medtronic, Inc. is recalling 661 CRT-D (cardiac resynchronization therapy defibrillator) devices, Model DTBA1D4 VIVA XT IS1/DF4 US. These are implantable cardioverter defibrillators designed to monitor heart rhythm and deliver electrical therapy when dangerous arrhythmias occur.

The recall addresses a rare manufacturing defect in a specific feedthrough component. This defect may result in reduced or no energy output during high-voltage therapy (typically 0–12 joules). The affected devices were distributed nationwide in the United States and worldwide.

Patients with these devices are at risk if dangerous cardiac arrhythmias occur and the device fails to deliver necessary electrical treatment. The FDA classified this as a Class I recall. Patients should contact their healthcare provider to determine if their device is affected.

The recalled product

Product
CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4; Implantable Cardioverter Defibrillators
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category
Medical Device — Implantable Cardiac Device
Hazard
Affected units
661

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)

  • GTIN 00643169720251
  • Lot Serial Numbers: BLE221424H
  • BLE221443H
  • BLE221244H
  • BLE221357H
  • BLE221415H
  • BLE221487H
  • BLE221190H
  • BLE221267H
  • BLE221842H
  • BLE221265H
  • BLE221430H
  • BLE221711H
  • BLE221346H
  • BLE221631H
  • BLE221285H
  • BLE221405H
  • BLE221436H
  • BLE221551H
  • BLE221411H

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 120 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 120 products in this recall →

Related recalls

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

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Same hazard · therapeutic failure

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