Medtronic CRT-D BRAVA Implantable Defibrillators—Potential High-Voltage Therapy Failure
Medtronic implantable cardioverter defibrillators with specific feedthrough components may fail to deliver high-voltage therapy during treatment. Affected units are being recalled due to risk of reduced or absent energy output.
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 recalls require minimum severity score 4. The hazard is potential failure of high-voltage therapy delivery in life-critical implantable defibrillators, with no reported incidents documented in this notice.
Plain-English summary
Medtronic Inc. is recalling approximately 7,994 units of the CRT-D BRAVA QUAD implantable cardioverter defibrillator (model DTBC2QQ) due to a rare potential for reduced or absent energy output during high-voltage therapy. The defect involves a specific type of feedthrough component in these devices. Affected units were distributed nationwide and worldwide.
Implantable cardioverter defibrillators are life-critical devices that detect and treat dangerous heart rhythms. If a device fails to deliver the intended high-voltage therapy during treatment, it cannot perform its primary function and may result in serious adverse health consequences for the patient.
Patients implanted with affected devices should contact their healthcare provider or Medtronic immediately to determine their device status. Medtronic is notifying healthcare facilities and providers. Patients should not discontinue cardiac monitoring or therapy without medical guidance, as the risk of an untreated dangerous heart rhythm may be greater than device-related risks in some cases.
The recalled product
- Product
- CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; Implantable Cardioverter Defibrillators
- Affected units
- 7,994
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 00643169720183
- Lot Serial Numbers: BLX611513S
- BLX610983S
- BLX610727S
- BLX609800S
- BLX610700S
- BLX611193S
- BLX611227S
- BLX610459S
- BLX613336S
- BLX611231S
- BLX610972S
- BLX610821S
- BLX611566S
- BLX611238S
- BLX610596S
- BLX610449S
- BLX610925S
- BLX611306S
- BLX610523S
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
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