Implantable Cardioverter Defibrillators Recalled for Potential High-Voltage Therapy Failure
Medtronic is recalling 7 implantable cardioverter-defibrillators that may fail to deliver electrical therapy during critical heart rhythms. The defect affects devices with a specific feedthrough component.
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 medical device recall. The devices are critical for preventing sudden cardiac death, and potential failure to deliver therapy could result in serious injury or death. Rule: FDA Class I classifications require a minimum severity of 4.
Plain-English summary
Medtronic is recalling a specific model of implantable cardioverter-defibrillator (CRT-D) device. The CRT-D DTBB2Q1 VIVA QUAD S is designed to monitor heart rhythm and deliver electrical therapy to correct dangerous arrhythmias.
Affected devices may experience reduced or completely absent energy output during high-voltage therapy (typically 0-12 joules). This defect is caused by a specific type of feedthrough component used in manufacturing. The recall affects 7 units distributed nationwide and internationally.
Patients with affected devices should contact their healthcare provider or Medtronic directly for guidance. Patients should not discontinue use of their device, as it may still provide essential protection. Medical professionals should verify device serial numbers against the recall notice to determine if their patients' devices are affected.
The recalled product
- Product
- CRT-D DTBB2Q1 VIVA QUAD S IS4/DF1 INTL, Model Number DTBB2Q1; Implantable Cardioverter Defibrillators
- Affected units
- 7
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 (8)
- GTIN 00643169980181
- Lot Serial Numbers: BLQ600039S
- BLQ600033S
- BLQ600034S
- BLQ600035S
- BLQ600036S
- BLQ600037S
- BLQ600038S
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 · therapy delivery failure
See all →- HighPhysio-Control Defibrillators May Lack Required Performance Inspection
FDA (Devices) · 2026-05-13
- SevereMedtronic Implantable Cardiac Defibrillators Risk Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereImplantable Defibrillators With Defective Feedthrough May Fail to Deliver Therapy
FDA (Devices) · 2023-06-28
- SevereImplantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
- CriticalImplantable Cardioverter Defibrillators Recalled for Potential High-Voltage Therapy Failure
FDA (Devices) · 2023-06-28
Similar recalls
- SevereMedtronic Recalls 78 Viva Quadripolar Implantable Cardioverter Defibrillators
FDA (Devices) · 2016-08-31
- SevereMedtronic Viva CRT-D Recall for Possible Prevention of Therapy
FDA (Devices) · 2018-02-28
- SevereMedtronic Cobalt Implantable Defibrillators Recalled Due to Reduced Shock Energy Defect
FDA (Devices) · 2022-08-17
- SevereCobalt Implantable Cardioverter Defibrillators recalled for reduced shock energy
FDA (Devices) · 2022-08-17
- SevereMedtronic Recalls CRT-D Devices Due to Shortened Replacement Time
FDA (Devices) · 2021-04-07
- SevereMedtronic Visia AF ICDs Recalled for Potential Therapy Failure
FDA (Devices) · 2018-02-28