The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1749-2023·Announced 2023-06-28

Implantable Cardiac Defibrillators Risk Therapy Failure Due to Feedthrough Defect

Certain Medtronic implantable cardiac defibrillators with specific glassed feedthrough components may deliver reduced energy during high-voltage therapy. This could prevent the device from functioning when needed in cardiac emergencies.

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: FDA Class I classification applies to devices where there is reasonable probability of serious adverse health consequences. Although no illnesses or injuries have been reported to date, the device's critical life-saving function and potential for therapy failure during cardiac emergencies warrant the Class I designation and Severe severity rating.

Plain-English summary

Medtronic Inc. is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), model CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, that were manufactured with specific glassed feedthrough components. The recall involves 7,921 units distributed nationwide in the United States and worldwide.

The affected devices may deliver reduced or no electrical energy output during high-voltage defibrillation therapy, which typically operates in the 0 to 12 joule range. This rare defect in the feedthrough component could prevent these life-saving devices from functioning properly during a critical cardiac emergency when the patient needs therapy most.

Patients with affected devices are identified by specific lot serial numbers listed in the recall notice. Healthcare providers and patients should contact Medtronic to determine whether their particular device is included in the recall based on the device's serial number and lot number.

The recalled product

Product
CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; Implantable Cardioverter Defibrillators
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category
Medical Device — Implantable Cardiac Defibrillator
Hazard
Affected units
7,921

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 00643169720367
  • Lot Serial Numbers: BLW607464S
  • BLW607601S
  • BLW607643S
  • BLW607705S
  • BLW607921S
  • BLW608132S
  • BLW608133S
  • BLW608134S
  • BLW608135S
  • BLW608235S
  • BLW608746S
  • BLW609769S
  • BLW606989S
  • BLW607809S
  • BLW607902S
  • BLW607917S
  • BLW607284S
  • BLW607004S
  • BLW607851S

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 →

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