Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output During Therapy
Certain implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators may fail to deliver adequate energy during high-voltage therapy due to a specific feedthrough defect. Medtronic is recalling 1,132 affected units.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I classification indicates a serious health hazard per agency determination. The potential for life-critical device malfunction during high-voltage therapy in implanted cardiac devices warrants critical severity, regardless of whether actual harms have been reported to date.
Plain-English summary
Medtronic Inc. is recalling 1,132 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), Model DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, due to a rare potential for reduced or no-energy output during high-voltage therapy (typically 0-12 joules). The issue affects devices manufactured with a specific glassed feedthrough component.
The affected devices are distributed nationwide in the United States and worldwide. The FDA has classified this as a Class I recall. Specific lot and serial numbers are available from the FDA.
Patients with these devices should contact their healthcare provider or Medtronic for guidance regarding their device.
The recalled product
- Product
- CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1; Implantable Cardioverter Defibrillators
- Affected units
- 1,132
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 00643169400603
- Lot Serial Numbers: BLH605909S
- BLH605759S
- BLH605781S
- BLH605675S
- BLH605010S
- BLH605692S
- BLH605674S
- BLH605156S
- BLH605237S
- BLH605376S
- BLH605837S
- BLH605887S
- BLH605736S
- BLH605691S
- BLH605953S
- BLH604859S
- BLH605700S
- BLH605904S
- BLH605933S
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
Similar recalls
- SevereCobalt Implantable Cardioverter Defibrillators recalled for reduced shock energy
FDA (Devices) · 2022-08-17
- SevereMedtronic Cobalt Implantable Defibrillators Recalled Due to Reduced Shock Energy Defect
FDA (Devices) · 2022-08-17
- SevereCobalt Implantable Defibrillators May Deliver Reduced Shock Energy
FDA (Devices) · 2022-08-17
- SevereCobalt Implantable Cardioverter Defibrillators May Deliver Reduced Shock Energy
FDA (Devices) · 2022-08-17
- SevereMedtronic Recalls 78 Viva Quadripolar Implantable Cardioverter Defibrillators
FDA (Devices) · 2016-08-31
- SevereMedtronic Visia AF ICDs Recalled for Potential Therapy Failure
FDA (Devices) · 2018-02-28