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.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- reduced-energy-output
- therapy-failure
- device-malfunction
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.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03