Medtronic implantable defibrillators recalled for potential therapy delivery failure
Medtronic has recalled certain implantable cardioverter defibrillators due to a rare risk of reduced or no energy output during high-voltage therapy.
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 applies, establishing a minimum severity of 4. The potential for reduced or no energy output in a life-saving defibrillator device presents serious clinical risk, though no injuries or deaths have been reported.
Plain-English summary
Medtronic Inc. has recalled certain CRTD CROME HF MRI IS1 DF1 implantable cardioverter defibrillators (Model DTPC2D1) manufactured with a specific feedthrough component. The affected devices have a rare potential for reduced or no energy output during high-voltage therapy, typically at 0-12 joules.
Affected units are identified by specific lot serial numbers and have been distributed nationwide and worldwide. The defect could prevent the device from delivering necessary therapeutic energy during treatment.
Patients who have received one of the affected devices should contact their healthcare provider or Medtronic immediately to determine if their device is affected. Healthcare providers should verify device lot numbers against the recall notice and consult with Medtronic regarding appropriate clinical management for affected patients.
The recalled product
- Product
- CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; Implantable Cardioverter Defibrillators
- Affected units
- 462
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 00763000178307
- Lot Serial numbers: RTX600076S
- RTX600084S
- RTX600139S
- RTX600148S
- RTX600114S
- RTX600308S
- RTX600386S
- RTX600327S
- RTX600334S
- RTX600372S
- RTX600046S
- RTX600048S
- RTX600066S
- RTX600108S
- RTX600261S
- RTX600345S
- RTX600586S
- RTX600382S
- RTX600388S
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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