The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1743-2023·Announced 2023-06-28

Implantable Defibrillators Recalled for Potential High-Voltage Therapy Failure

Medtronic CRT-D and ICD devices with a specific feedthrough may fail to deliver high-voltage therapy. The FDA Class I recall affects multiple lot numbers due to rare potential for reduced or no energy output during critical treatment.

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: "There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with…"

Plain-English summary

Medtronic Inc. is recalling specific lots of its CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US implantable cardioverter defibrillators (ICDs and CRT-Ds). These devices were manufactured with a specific glassed feedthrough component.

There is a rare potential for reduced or no energy output during high-voltage therapy (typically 0-12J) in affected devices. This defect could prevent the device from delivering critical therapy when needed.

The recall applies to implantable defibrillators distributed nationwide and worldwide. Affected devices are identified by specific lot serial numbers provided in the FDA recall notice.

Patients implanted with potentially affected devices should contact their healthcare provider or Medtronic to determine whether their device is included in the recall.

The recalled product

Product
CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US, Model Number DTBB1Q1; Implantable Cardioverter Defibrillators
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category
Medical Device — Implantable Defibrillator
Hazard

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 00643169720206
  • Lot Serial Numbers: BLM202912H
  • BLM203000H
  • BLM202895H
  • BLM202965H
  • BLM203007H
  • BLM203028H
  • BLM203031H
  • BLM203063H
  • BLM202844H
  • BLM202900H
  • BLM203042H
  • BLM203014H
  • BLM203015H
  • BLM203062H
  • BLM202811H
  • BLM202838H
  • BLM202857H
  • BLM202858H
  • BLM202881H

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)

See all →

Same hazard · energy output failure

See all →

Similar recalls