Medtronic Implantable Cardiac Defibrillators Risk Therapy Delivery Failure
Medtronic is recalling certain CRT-D and ICD models due to a potential feedthrough defect that may prevent energy delivery during high-voltage therapy. The FDA Class I recall affects 435 units distributed in the United States and worldwide.
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. Per the rubric, Class I recalls score no lower than 4 (Severe). No reported deaths, injuries, or illnesses are mentioned in the source, so the score is 4 rather than 5.
Plain-English summary
Medtronic is recalling specific models of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), Model DTBB2D4 VIVA S IS1/DF4 INTL, due to a potential electrical defect in the feedthrough component. Approximately 435 units are affected.
The devices may experience reduced or no-energy output during high-voltage therapy, typically in the 0-12J range, due to a specific glassed feedthrough. Because these implanted devices are designed to treat dangerous heart rhythms, failure to deliver appropriate therapy could have serious consequences for patients who depend on them.
The affected devices were distributed in the United States and worldwide. Patients who have received one of these devices should contact their healthcare provider to determine if their device is affected.
The recalled product
- Product
- CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; Implantable Cardioverter Defibrillators
- Affected units
- 435
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 00643169720299
- Lot Serial Numbers
- BLR602282S
- BLR602271S
- BLR602274S
- BLR602363S
- BLR602366S
- BLR602278S
- BLR602289S
- BLR602365S
- BLR602238S
- BLR602293S
- BLR602325S
- BLR602332S
- BLR602333S
- BLR602334S
- BLR602336S
- BLR602337S
- BLR602340S
- BLR602353S
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
- 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
- SevereImplantable Defibrillators May Fail to Deliver Therapy During Critical Events
FDA (Devices) · 2023-06-28
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