Medtronic CRT-D Defibrillators Recalled for Potential Therapy Output Failure
Medtronic implantable cardiac defibrillators (CRT-D) may deliver reduced or no energy during critical high-voltage therapy due to a feedthrough defect. The recall affects 193 units that could fail to deliver lifesaving defibrillation shocks when needed.
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 classified this recall as Class I, establishing a minimum severity of 4 per the rubric. Although no deaths or serious injuries have been reported, the potential for defibrillation therapy failure in a life-critical implantable cardioverter warrants a Severe rating.
Plain-English summary
Medtronic is recalling CRT-D VIVA QUAD S IS4/DF4 implantable cardioverter defibrillators (model DTBB1QQ). These devices are implanted in patients' chests to monitor heart rhythm and deliver electrical therapy when abnormal heartbeats are detected. The recall involves 193 units distributed nationwide in the US and worldwide.
Affected devices may have a rare defect in the glassed feedthrough component that could cause reduced or no energy output during high-voltage defibrillation therapy (typically 0-12 joules). This means the device might fail to deliver the necessary electrical shock when needed to correct dangerous heart rhythms.
All recalled devices are identified by specific lot serial numbers, including BLK205268H, BLK205272H, BLK205461H, and 190 additional lot numbers listed in the FDA recall notice (Z-1744-2023). Patients should check with their healthcare provider to determine if their implanted device is affected.
If you have an implanted device from an affected lot number, contact your cardiologist or healthcare provider immediately. Your medical team can determine whether your device is affected and discuss appropriate next steps based on your individual medical condition.
The recalled product
- Product
- CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ; Implantable Cardioverter Defibrillators
- Affected units
- 193
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 00643169720145
- Lot Serial Numbers: BLK205268H
- BLK205272H
- BLK205461H
- BLK205544H
- BLK205582H
- BLK205328H
- BLK205358H
- BLK205475H
- BLK205492H
- BLK205304H
- BLK205346H
- BLK205364H
- BLK205269H
- BLK205352H
- BLK205349H
- BLK205400H
- BLK205432H
- BLK205451H
- BLK205309H
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 failure
See all →- HighImplantable Vagus Nerve Stimulation Device May Stop Delivering Therapy
FDA (Devices) · 2025-02-05
- HighV.A.C. Ulta Therapy Units Recalled Due to Occlusion Sensor Failures
FDA (Devices) · 2024-12-04
- HighReplacement Lead Wires Recalled for Risk of Treatment Delivery Failure
FDA (Devices) · 2024-05-01
- HighOPTIMIZER CCM X11 Implantable Pulse Generator May Fail to Deliver Therapy
FDA (Devices) · 2024-02-28
- SeverePercussionaire Distal Phasitron respiratory device with reservoir bag assembly defect recalled
FDA (Devices) · 2024-01-24
Similar recalls
- SevereMedtronic Recalls 78 Viva Quadripolar Implantable Cardioverter Defibrillators
FDA (Devices) · 2016-08-31
- SevereMedtronic Cobalt Implantable Defibrillators Recalled Due to Reduced Shock Energy Defect
FDA (Devices) · 2022-08-17
- HighMedtronic Implantable Defibrillators Recalled for Manufacturing Weld Defect
FDA (Devices) · 2024-07-03
- SevereMedtronic Viva CRT-D Recall for Possible Prevention of Therapy
FDA (Devices) · 2018-02-28
- HighMedtronic Implantable Cardioverter Defibrillator Recalled for Manufacturing Weld Defect
FDA (Devices) · 2024-07-03
- SevereMedtronic Recalls CRT-D Devices Due to Shortened Replacement Time
FDA (Devices) · 2021-04-07