Implantable Defibrillator Recall: Risk of Failed High-Voltage Therapy
Medtronic implantable defibrillators may fail to deliver therapy due to a defective feedthrough component. 207 units recalled nationwide 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 classified this as a Class I recall, the highest safety designation for medical devices. Although the hazard is described as rare and potential with no reported illnesses or deaths, the device failure could prevent critical defibrillation therapy in life-threatening situations.
Plain-English summary
Medtronic is recalling 207 units of CRT-D DTBB1D1 VIVA S implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) containing a defective feedthrough component.
The defective feedthrough creates a rare potential for reduced or no energy output during high-voltage therapy (typically 0-12 joules). This could prevent the device from delivering necessary defibrillation therapy to correct dangerous heart rhythms.
The affected devices were distributed nationwide and worldwide. The recall involves 207 units with specific lot serial numbers. Patients should verify their device serial number with Medtronic or their healthcare provider to determine if their device is affected.
The FDA has classified this as a Class I recall, indicating the highest level of safety concern. Patients with these devices should contact Medtronic for further instructions regarding replacement or additional monitoring.
The recalled product
- Product
- CRT-D DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1; Implantable Cardioverter Defibrillators
- Affected units
- 207
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 00643169720329
- Lot Serial Numbers: BLO214422H
- BLO214561H
- BLO214374H
- BLO214534H
- BLO214440H
- BLO214546H
- BLO214564H
- BLO214574H
- BLO214347H
- BLO214424H
- BLO214577H
- BLO214311H
- BLO214464H
- BLO214492H
- BLO214410H
- BLO214276H
- BLO214283H
- BLO214290H
- BLO214368H
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
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