Implantable cardioverter defibrillators may output reduced or no energy during therapy
Medtronic ICDs and CRT-Ds with specific feedthroughs may fail to deliver adequate high-voltage therapy. This FDA Class I recall affects 487 units distributed nationwide and worldwide.
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: This recall carries FDA Class I classification, which per the rubric mandates a minimum severity score of 4. The potential for reduced or absent high-voltage therapy delivery in implantable defibrillators poses significant risk to cardiac patients.
Plain-English summary
Medtronic Inc. is recalling ICD CROME DR MRI IS1 DF1 (Model DDPC3D1) implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific glassed feedthrough component.
These devices carry a rare potential for reduced or no energy output during high-voltage (HV) therapy, typically 0-12 joules. This could prevent the device from delivering adequate life-saving therapy to correct dangerous heart rhythms.
The recall affects 487 units with worldwide distribution. It includes currently available ICDs and CRT-Ds manufactured with the affected feedthrough component.
Patients with these devices should contact their healthcare provider or Medtronic directly to determine if their specific device is affected and what monitoring or corrective actions may be needed.
The recalled product
- Product
- ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- reduced-energy-output
- therapy-failure
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 00763000178413
- Lot Serial Numbers: RSP600249S
- RSP600057S
- RSP600253S
- RSP600085S
- RSP600014S
- RSP600150S
- RSP600148S
- RSP600089S
- RSP600091S
- RSP600114S
- RSP600189S
- RSP600210S
- RSP600394S
- RSP600130S
- RSP600216S
- RSP600256S
- RSP600386S
- RSP600149S
- RSP600245S
Distribution
Distributed nationwide across the United States.
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