Medtronic CRT-D Implants Recalled for Rare Energy Output Failure Risk
Medtronic is recalling certain CRT-D (cardiac resynchronization therapy defibrillator) models due to a rare risk of reduced or no energy output during high-voltage therapy. The FDA has classified this as a Class I recall affecting 1,473 units.
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 recall, which mandates minimum severity score of 4 per the rubric. The defect affects implantable cardiac devices critical to patient therapy delivery.
Plain-English summary
Medtronic Inc. is recalling the CRT-D DTBA1D1 VIVA XT IS1/DF1 model implantable cardioverter defibrillators due to a rare potential for reduced or no energy output during high-voltage (HV) therapy, typically delivered at 0-12 joules. This defect is related to a specific type of feedthrough used in manufacturing these devices and could prevent the device from delivering therapy when needed.
This FDA Class I recall affects 1,473 units distributed nationwide and worldwide. The recalled devices are identified by specific lot serial numbers beginning with BLF (with either H or S suffixes) and GTIN codes 00643169720312 and 00763000059545.
Patients who have received one of these recalled CRT-D devices should contact their healthcare provider or Medtronic immediately to determine if their device is affected. Healthcare providers should verify patient device lot numbers and serial numbers against the recall list. Patients should not discontinue use of their device without consulting their physician, as the underlying condition for which the device was implanted remains a medical concern.
The recalled product
- Product
- CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; Implantable Cardioverter Defibrillators
- Affected units
- 1,473
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 00643169720312
- Lot Serial Numbers: BLF258142H
- BLF257918H
- BLF258186H
- BLF258209H
- BLF257508H
- BLF258084H
- BLF257081H
- BLF257089H
- BLF257260H
- BLF257290H
- BLF257410H
- BLF257440H
- BLF257565H
- BLF257668H
- BLF257684H
- BLF257873H
- BLF257966H
- BLF256897H
- BLF257648H
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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