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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- therapy-failure
- device-malfunction
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.
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