Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
Medtronic is recalling 1,754 CRT-D and ICD implantable defibrillators with a specific feedthrough component that may not deliver therapy when needed. Devices were distributed nationwide and worldwide.
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: This recall is classified as FDA Class I, which requires a minimum severity of Severe (4) per the classification guidance. The issue involves a life-critical implantable medical device with potential for therapy delivery failure, which could directly affect patient safety.
Plain-English summary
Medtronic Inc. is recalling certain CRT-D DTBC2Q1 BRAVA QUAD implantable cardioverter defibrillators (ICDs) and CRT-D devices due to a rare potential for reduced or no-energy output during high voltage therapy. The issue affects devices manufactured with a specific glassed feedthrough component, including currently available devices.
The recall involves 1,754 units that have been distributed nationwide and internationally. The affected devices may experience reduced or absent energy output during high voltage therapy (typically 0-12J), which could prevent necessary electrical therapy delivery in critical cardiac rhythm situations.
The recalled product
- Product
- CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 INTL, Model Number DTBC2Q1; Implantable Cardioverter Defibrillators
- Affected units
- 1,754
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 00643169720244
- Lot Serial Numbers: BLY602416S
- BLY602685S
- BLY602482S
- BLY602743S
- BLY602431S
- BLY602548S
- BLY602563S
- BLY602693S
- BLY602474S
- BLY602424S
- BLY602465S
- BLY602812S
- BLY602676S
- BLY602445S
- BLY602572S
- BLY602497S
- BLY602549S
- BLY602715S
- BLY602735S
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 →- SevereImplantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28
Same hazard · reduced energy output
See all →- SevereImplantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereImplantable defibrillators may deliver reduced or no energy during therapy
FDA (Devices) · 2023-06-28
- SevereImplantable cardioverter defibrillators may output reduced or no energy during therapy
FDA (Devices) · 2023-06-28
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