Implantable Cardioverter Defibrillators Risk Reduced Energy Output During Therapy
Medtronic's implantable cardioverter defibrillators may produce reduced or no energy during high voltage therapy due to a feedthrough defect. A total of 1,076 units are affected 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: The FDA has classified this as a Class I recall, the agency's most serious classification for medical devices, indicating a potential for serious patient harm. Although no illnesses or deaths have been reported, the hazard affects the critical therapeutic function of life-saving implantable devices.
Plain-English summary
Medtronic Inc. is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), specifically model DTBB2D1 VIVA S IS1/DF1 INTL. These devices were manufactured with a specific glassed feedthrough component that poses a safety risk. A total of 1,076 units have been identified as affected and distributed in the United States and internationally.
The devices carry a rare potential for reduced or no energy output during high voltage therapy, typically at energy levels of 0 to 12 joules. This defect could prevent the affected devices from delivering adequate therapy when needed.
The recall affects specific lot serial numbers of the devices. Patients and healthcare providers should identify affected units using the lot numbers and serial numbers provided in the official recall notice. The affected devices are being recalled due to this manufacturing defect related to the feedthrough component.
The recalled product
- Product
- CRT-D DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1; Implantable Cardioverter Defibrillators
- Affected units
- 1,076
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 00643169720350
- Lot Serial Numbers: BLS604430S
- BLS604248S
- BLS604229S
- BLS604258S
- BLS604234S
- BLS604223S
- BLS604309S
- BLS604224S
- BLS604227S
- BLS604222S
- BLS604308S
- BLS604256S
- BLS604257S
- BLS604310S
- BLS604313S
- BLS604245S
- BLS604253S
- BLS604252S
- BLS604239S
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 · reduced energy output
See all →- SevereImplantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereImplantable defibrillators may deliver reduced or no energy during therapy
FDA (Devices) · 2023-06-28
- SevereImplantable cardioverter defibrillators may output reduced or no energy during therapy
FDA (Devices) · 2023-06-28
Similar recalls
- SevereCobalt Implantable Cardioverter Defibrillators recalled for reduced shock energy
FDA (Devices) · 2022-08-17
- SevereCobalt Implantable Cardioverter Defibrillators May Deliver Reduced Shock Energy
FDA (Devices) · 2022-08-17
- SevereMedtronic Cobalt Implantable Defibrillators Recalled Due to Reduced Shock Energy Defect
FDA (Devices) · 2022-08-17
- SevereMedtronic Recalls 78 Viva Quadripolar Implantable Cardioverter Defibrillators
FDA (Devices) · 2016-08-31
- SevereCobalt Implantable Defibrillators May Deliver Reduced Shock Energy
FDA (Devices) · 2022-08-17
- SevereMedtronic EnTrust ICD Recall for Potential Loss of High Voltage Therapy
FDA (Devices) · 2018-07-18