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.
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: 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
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- 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 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.
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