Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
Medtronic is recalling 1,754 CRT-D and ICD implantable defibrillators with a specific feedthrough component that may not deliver therapy when needed. Devices were distributed nationwide and worldwide.
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: This recall is classified as FDA Class I, which requires a minimum severity of Severe (4) per the classification guidance. The issue involves a life-critical implantable medical device with potential for therapy delivery failure, which could directly affect patient safety.
Plain-English summary
Medtronic Inc. is recalling certain CRT-D DTBC2Q1 BRAVA QUAD implantable cardioverter defibrillators (ICDs) and CRT-D devices due to a rare potential for reduced or no-energy output during high voltage therapy. The issue affects devices manufactured with a specific glassed feedthrough component, including currently available devices.
The recall involves 1,754 units that have been distributed nationwide and internationally. The affected devices may experience reduced or absent energy output during high voltage therapy (typically 0-12J), which could prevent necessary electrical therapy delivery in critical cardiac rhythm situations.
The recalled product
- Product
- CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 INTL, Model Number DTBC2Q1; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- reduced-energy-output
- no-energy-output
- therapy-failure
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 00643169720244
- Lot Serial Numbers: BLY602416S
- BLY602685S
- BLY602482S
- BLY602743S
- BLY602431S
- BLY602548S
- BLY602563S
- BLY602693S
- BLY602474S
- BLY602424S
- BLY602465S
- BLY602812S
- BLY602676S
- BLY602445S
- BLY602572S
- BLY602497S
- BLY602549S
- BLY602715S
- BLY602735S
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- ModerateMedtronic DLP Retrograde Cannula Model 94965 Sterile Barrier Breach
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 13FR Model 94913L Recall
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27
- ModerateOneLIF Interbody Cage Inserter Attachment Failure Recall
FDA (Devices) · 2026-05-27
- HighMedtronic GUNDRY Retrograde Cannula Model 94113T sterile barrier recall
FDA (Devices) · 2026-05-27