Implantable Defibrillators May Fail to Deliver Therapy During Critical Events
Certain Medtronic implantable defibrillators may fail to deliver energy during high-voltage therapy due to a feedthrough manufacturing defect. 523 units distributed worldwide are affected.
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 classification for this life-critical cardiac implant device mandates a minimum severity rating of 4. While no deaths or illnesses have been reported and the defect is described as rare, failure to deliver therapy during a critical cardiac event could be fatal.
Plain-English summary
Medtronic Inc. is recalling implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), model DTBB2QQ VIVA QUAD S IS4/DF4 INTL. These are devices implanted to monitor heart rhythm and deliver electrical therapy for abnormal heartbeats.
The recalled devices may have a rare manufacturing defect in a specific feedthrough component. This defect can cause reduced or no energy output during high-voltage therapy (typically 0-12 joules). If this malfunction occurs when the device is needed to treat an abnormal heart rhythm, the necessary therapy may not be delivered.
A total of 523 units have been distributed in the US and worldwide. Patients with one of the affected lot serial numbers should contact their implanting physician or Medtronic immediately to verify whether their device is affected and to discuss what action should be taken.
The recalled product
- Product
- CRT-D DTBB2QQ VIVA QUAD S IS4/DF4 INTL, Model Number DTBB2QQ; Implantable Cardioverter Defibrillators
- Affected units
- 523
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 00643169720176
- Lot Serial Numbers: BLP603514S
- BLP603579S
- BLP603583S
- BLP603637S
- BLP603643S
- BLP603554S
- BLP603588S
- BLP603580S
- BLP603582S
- BLP603584S
- BLP603585S
- BLP603586S
- BLP603591S
- BLP603531S
- BLP603552S
- BLP603511S
- BLP603647S
- BLP603581S
- BLP603545S
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
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- 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
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