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.
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: 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 →- CriticalMedtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillators Recalled for Reduced Therapy Output
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28
Same hazard · reduced energy output
See all →- SevereImplantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
- 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
- SevereImplantable Cardioverter Defibrillators Recalled for Potential Reduced Energy Output
FDA (Devices) · 2023-06-28